It used to be that people with diabetes needed to use “finger sticks” to draw a small amount of their blood throughout the day in order to check their sugar levels. When continuous glucose monitors (CGMs) were introduced, they were considered a “complete game changer,” as one medical school professor put it.
Using CGMs that are usually attached to the arm, diabetics can read their blood sugar levels using an app on their phones whenever they like. These apps are also supposed to alert people when their levels are too low or high.
This technology, like any, can break down. The professor notes that in some cases, ”when it does, it’s a life-or-death situation.”
“Medical device correction” issued
Last November, Abbott issued a “medical device correction” for approximately 3 million of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors throughout the country. The press release from the manufacturer said that “some sensors may provide incorrect low glucose readings.”
At that point, the company said it knew of 57 “severe adverse events” in the U.S. and hundreds more worldwide as well as seven fatalities (all outside the U.S.) that were “potentially associated with this issue.” Those numbers have since grown, including at least one U.S. man’s death not included in the official count that surviving family members link to the defect.
Recall didn’t eliminate access to defective devices
A recall later followed the press release from Abbott. Unfortunately, that didn’t protect everyone from obtaining a potentially faulty CGM, even from hospitals, or from receiving incomplete information about the severity of the risk of the faulty monitors.
In one case, a doctor at a large trauma center realized he’d sent a patient home with one. One Marine veteran said he received a notice of the recall from the VA, but it didn’t note that the problem had already been associated with multiple fatalities
Patients are urged to maintain a supply of finger sticks in case their CGM doesn’t work or their reading doesn’t align with their symptoms. However, most people are used to relying on the data they get from their CGMs.
When manufacturers and other parties fail to keep these defective medical devices out of people’s hands and patients suffer harm as a result, it’s crucial to hold all liable parties responsible. Getting experienced legal guidance is a good first step.
