Need to know
- In November 2019, the TGA issued a product defect notification for Roche Accu-Chek Guide and Performa blood glucose meters, but it didn't recall the malfunctioning devices
- In May 2020, a women named 'Amy' purchased an Accu-Chek Guide that stopped working after a single use – it had the electronic fault that the TGA had flagged
- Roche admits selling a "considerable number" of these faulty devices, but it doesn't warn people with diabetes on the packaging or in its marketing about the defect
Having a reliable blood glucose meter on hand to check blood sugar levels is a medical necessity for many people who have diabetes. When the levels are too high or too low, serious and long-lasting health problems can follow if the imbalance isn't corrected.
It would be fair to assume, then, that the businesses making blood glucose meters would make sure they're in good working order before bringing them to market.
That's not the case with the Australian arm of one of the biggest pharmaceutical and medical device companies in the world, Roche.
CHOICE recently discovered that an unknown number of defective Accu-Chek Guide and Accu-Chek Performa blood glucose meters sold by Roche Diabetes Care Australia are currently for sale on pharmacy shelves around the country, and that Roche knows the products are faulty.
Roche knew about the defects before it shipped the product
In fact, Roche knew about the defects before it shipped the product. But diabetes sufferers have been left in the dark. A woman with diabetes who we'll call Amy recently bought an Accu-Chek Guide.
"Yesterday I purchased a blood glucose meter from my local pharmacy," Amy told us in early May this year. "This morning I discovered that the batteries had failed after only 15 minutes of use the previous evening. I then checked online reviews, only to discover lots of other people with similar problems."
TGA aware of the problem
In November 2019, the Therapeutic Goods Administration (TGA) published a warning about the product that Amy purchased, the Accu-Chek Guide.
The TGA warning said both devices were prone to battery failure and that users should "always have a spare set of high-quality batteries" and "have a back-up testing method available".
But none of this information came with the Accu-Chek device Amy bought from her local pharmacist. Nor was it (or is it) included on Roche Australia's web page advertising the product.
Instead, the packaging came with a paper note that alluded to the battery issue, saying users should remove and then reinsert the batteries if they got an "electronic error" message.
If the message reappeared, users should "change the batteries now", the note instructed.
This is the current level of Roche's disclosure of the electronic fault to diabetes sufferers, unless you happen to come across the TGA notice.
The old defective models were not recalled and are still for sale around the country
"I thought it would be no problem to clear an occasional error message, and, as someone who knows the consumer guarantees, if the batteries were faulty, I would get the supplier to send me replacements," Amy told us.
"There was no other indication in or on the box of the more serious problems identified by the TGA, or that the meter itself might run the batteries down because it is faulty," she added.
Finding new batteries for the device amid the COVID-19 shutdown would not be easy, Amy told us. The batteries are also not cheap.
In its November 2019 warning the TGA said: "Roche Diabetes Care Australia is investigating these issues to identify the root cause and is already implementing corrective measures, such as design improvements, to address them in new models."
But the old defective models were not recalled and are still for sale around the country.
People who buy a defective Roche Accu-Chek blood glucose meter won't find out about the defect until they open the box.
Roche keeps the issue under wraps
As a person with diabetes, Amy says the information about the electronic fault should be 'front and centre", not limited to a TGA warning that Roche Australia fails to make its customers aware of.
"I am concerned that Roche is knowingly selling a faulty blood glucose meter," Amy says. "I checked with our pharmacist, and the faulty one that I purchased was recent stock. It did not come with a warning about battery problems, or any of the information on the TGA page, just a small slip of paper saying how to clear an error message when you first turn on the device.
"It is in the range of problem serial numbers. Our pharmacist was surprised and concerned when we told him about the TGA notice. Why are they still shipping them?"
Our pharmacist was surprised and concerned when we told him about the TGA notice. Why are they still shipping them?
'Amy', diabetes sufferer
After her Accu-Chek meter stopped working, Amy contacted Roche Diabetes Care Australia's Accu-Chek Enquiry Line by email.
Five days later she got a response from Roche that was couched in techno-babble: "We would need to complete some mandatory, meter/strip specific troubleshooting in order to determine the potential cause of the issue/s being experienced and ensure the meter is registered for warranty."
Amy was told to call Roche Australia during working hours and to "have your meter and strips available at the time of the call".
There was no mention of the known battery problem or the TGA notice.
The note Roche added to the Accu-Chek box is hardly a model of transparency – it left our case study contributor, Amy, scratching her head.
Roche 'working closely' with the TGA
It was only when Amy contacted Roche Australia a second time and mentioned the TGA notice that Roche acknowledged the battery issue, saying, "We worked closely with the TGA regarding this product notification, and we provided this information to ensure customers are aware of delayed therapy due to potential battery issues." (As above, customers would only be aware if they went looking for the TGA notice.)
At this point, Roche requested the serial number of Amy's Accu-Chek and asked her to describe the problem again.
Roche Australia says it followed protocol
Roche Diabetes Care Australia General Manager for Australia and New Zealand, Jane Crowe, told CHOICE the company followed the proper steps when it discovered the Accu-Chek meters were faulty.
"This was a global decision, and we followed the normal process and fully disclosed our position to the TGA and the ACCC," Crowe says. "The TGA made the decision that it was a product defect notification and not a recall, which is why there is still defective product out there. That's their decision."
At the TGA's request, Roche also alerted everyone on its customer database as well as partner organisations with a stake in diabetes care about the defect, Crowe says.
We don't know how many defective products are out there, but we haven't been selling those serial numbers for some time
Jane Crowe, General Manager Roche Diabetes Care
But it obviously continued to ship the faulty meters, otherwise the note wouldn't have been added to the packaging. Crowe doesn't dispute this.
Due to the high volume of Accu-Chek products it has shipped and the different parties involved in wholesaling and distributing them, Roche has no way of knowing how many of its faulty blood glucose meters are still for sale, Crowe says, but acknowledges that "we sold a considerable amount" that made their way to retailers.
"We don't know how many defective products are out there, but we haven't been selling those serial numbers for some time," Crowe says.
'Not everyone complains'
She estimates that about one percent of customers who have purchased one of the affected stock of Accu-Chek meters have complained. "There haven't been many complaints, but we know that not everyone complains."
Crowe says that the Accu-Chek webpage included a warning about the defect when it was first discovered, but the warning was taken down with the TGA's approval.
As for the cryptic wording on the paper slip that comes with the faulty Accu-Chek products, Crowe says CHOICE's inquiry into the matter will have Roche looking into the shortcomings of that notification with any eye to communicating the defect more clearly to customers.
Health academic: Both Roche and the TGA should have done better
Ken Harvey, an Associate Professor of Public Health and Preventive Medicine at Monash University and a longtime advocate for consumer rights in the healthcare sector, told CHOICE that the level of disclosure in both the TGA notice and the note inside the Accu-Chek packaging falls short of the mark.
(Among other appointments, Harvey recently served on the TGA's Transparency Review Panel.)
Regrettably, the TGA has a long history of accepting what product sponsors and manufactures say without any follow up.
Ken Harvey, Associate Professor of Public Health and Preventative Medicine at Monash University
The TGA notice, for instance, gives guidance on how to potentially correct the fault with the glucose meter, but it stops there, Harvey says.
"The notice is silent about whether the fault can happen again after taking steps to correct it, such as by inserting new batteries," Harvey says. "The TGA or Roche or both of them should have clarified this. Even in the absence of a recall, there is a consumer protection issue. Regrettably, the TGA has a long history of accepting what product sponsors and manufactures say without any follow up."
The notice also gives a range of serial numbers for affected products but doesn't say when the products were supplied or whether the fault has been fixed on other serial numbers, Harvey points out.
Returns and refunds?
Advice on returning the product for a refund is also missing. "Roche has supplied a defective product that should entitle the purchaser to a replacement under Australian Consumer Law," Harvey says. "This should have been offered."
"It is also unacceptable that a patient would only learn of this fault from a slip of paper after purchasing the product," Harvey says. "Why not a warning sticker fixed on the outside of the packaging? Better yet, the offer of a newer product certified as not faulty."
The TGA should have also required Roche to send a letter to all GPs and endocrinologists and diabetologists advising them of the faulty meter and clarifying whether the fault can occur on products beyond the cited serial numbers.
"In my opinion, the TGA should have only allowed Roche to continue supplying these meters given a written undertaking by Roche that it would take all of these steps," Harvey says.
TGA says devices 'no longer being sold'
A TGA spokesperson told CHOICE that its November 2019 notification "included detailed information for consumers, and advice that the reported issue only impacts a specific serial number range which are no longer being sold in Australia".
Roche says it's no longer selling the defective meters to pharmacies, however, the pharmacies are still selling them – a critical point that the regulator did not address.
Further, the TGA's stand on selling defective products seems to indicate that Roche's adding a note to the Accu-Chek product packaging warning of its defects would be a regulatory violation. If there were defects, the devices shouldn't have been sold at all.
The TGA does not support the sale of affected devices. Knowingly supplying defective medical devices may be an offence.
TGA spokesperson
"The Therapeutic Goods Act 1989 requires all medical devices sold in Australia to demonstrate ongoing compliance for quality, safety and performance," the spokesperson said.
"The TGA does not support the sale of affected devices relevant to the serial number range specified. Knowingly supplying defective medical devices may be an offence under the Act."
And while the defective Accu-Chek meters were not recalled, the TGA says consumers and doctors who come across one should alert the regulator.
"The TGA agreed for Roche to undertake a product defect correction, which is a type of 'recall action' defined by the Uniform Recall Procedure for Therapeutic Goods. The TGA continues to encourage consumers and health professionals to submit suspected adverse event reports, and the TGA will continue to monitor these and take appropriate action where necessary."
Exercising your refund rights
More than two weeks after she first contacted the company, Roche Australia sent Amy some replacement batteries.
But she's had enough of her Accu-Chek meter. She got a refund from the pharmacy and bought a different brand. She also lodged complaints with Consumer Affairs Victoria and the ACCC.
This experience has shown me that it seems to be legal for a company to keep selling faulty items even once serious faults are known
Amy
"No word from Roche on recalling the faulty products, but I guess that's not surprising seeing as the decision not to do a recall must have been made some time ago," Amy says.
"I thought I knew a bit about Australian consumer law, but this experience has shown me that it seems to be legal for a company to keep selling faulty items even once serious faults are known. It also seems to be legal for the company not to advise the customer about the faults before the sale. That seems shocking in regards to an important medical device. I imagine most people would think it would have to be withdrawn from sale."
Have you bought a faulty Accu-Chek blood glucose meter?
Under Australian Consumer Law, you have a right to a refund for a product with a major problem. The ACCC defines a major problem as one "that would have stopped someone from buying it if they'd known about it".
The law also says the store where you bought the product has to provide the refund. The retailer is not allowed to fob you off and tell you to take the issue up with Roche Australia, although you are welcome to do so. And remember, it's against the law for a retailer to have a 'no refunds' or 'no refunds or exchanges on sale items' policy.
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Stock images: Getty, unless otherwise stated.
