Insulin pumps, blood glucose monitors and even diabetic testing strips can fail, causing inaccurate readings or even delivering the wrong amount of insulin. When they do, the results can be tragic.
According to an investigation by Consumer Reports, diabetes devices are responsible for more adverse event reports submitted to the FDA than any other category of medical device. Adverse event reports include reports of malfunction, injury or death.
Consumer Reports highlighted several incidents where a diabetes device failed and caused either serious injury or death. For example, Pamela (last name withheld) had been using a Medtronic insulin pump for three years when it reportedly malfunctioned one night in 2016.
As she and her husband slept, the pump delivered enough insulin in one night for five or six days. It sent her blood sugar levels plummeting until she went into a coma. She could not be revived and died a week later.
According to Consumer Reports, Medtronic knew this infusion set had this flaw at least two months before Pamela began using it in 2013. It issued an Urgent Medical Device Safety Notification in June of that year. In July 2013, the FDA concluded it didn’t need to issue a public statement about the device because Medtronic “appears to have properly informed the public.”
Medtronic recalled the faulty device in 2017, but not until four years after the problem was identified and only after inventory of the devices had been depleted.
Although Medtronic insisted that Pamela’s death was caused by user error, a lawsuit by Pamela’s husband claims that Medtronic never notified patients about the possibility of extra doses being administered. Pamela’s case was later settled out of court.
No single product is to blame
Although Medtronic’s insulin pump may have a flaw, that company is not the only one to experience adverse events. According to the investigation, nearly 400 deaths and 66,000 injuries were reported between January 2019 and 2020 in cases involving commonly used diabetes devices.
Products by Medtronic, Abbott Laboratories, Dexcom and Tandem Diabetes Care were all cited in the adverse event reports. Each device appears to have its own potential for error.
Unfortunately, diabetes is a complex disease requiring constant patient involvement. And, many patients use several devices in tandem.
Often, Consumer Reports says, the FDA is overwhelmed with adverse event reports and can’t keep on top of the red flags that could lead to a more expeditious recall.
Steps you can take to protect yourself
Get a demonstration of the device before you buy. Some pumps may be more intuitive to use than others. It’s crucial to feel confident you can operate the device accurately.
Know that glucose meters can give inaccurate, inconsistent results. Glucose meters require you to prick your finger and squeeze the blood onto a test strip. Unfortunately, factors like altitude and humidity can affect the readings. So can dehydration or anemia. Wash and dry your hands before you use the strips. Keep them in a closed vial, and don’t use old strips. Even then, take the reading with a grain of salt and retest if you get a surprising result.
Sign up for safety alerts with the FDA. It’s crucial to know if your device is recalled or has a corrective action taken. Register your device to your current address and sign up for FDA alerts.
Don’t ignore difficulties with the device. Don’t assume it’s your fault or just a fluke. Call your doctor or the manufacturer’s hotline for help with any problem. This also may alert the company to the issue.
Report difficulties or malfunctions immediately to the FDA and the manufacturer. They both rely on consumers to report problems and help hold the companies accountable.
If you are injured or lose a loved one, discuss your case with an attorney who handles medical product liability cases. They can help you discover whether the device was faulty and help you hold the right parties responsible, so the same problem doesn’t happen to another family.