BREAKING NEWS Recall for medical device used by 38m Americans over malfunction that could lead to death
An urgent recall has gone out for a popular medical devices used by millions of Americans with diabetes.
The US Food and Drug Administration (FDA) has revealed that over two million blood glucose monitors from Dexcom could fail to give the audible warning that the wearer is dealing with high or low blood sugar levels.
This could lead to users to miss critical warnings, increasing the risk of serious health problems like seizures, vomiting, fainting, or even death from untreated hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).
The recall effects the Dexcom G6 Glucose Receiver, Dexcom G7 Glucose Receiver, Dexcom One+ Continuous Glucose Monitoring System, and the Dexcom One Continuous Glucose Monitoring Syste.
In total, 2,230,770 Dexcom devices are a part of the recall. The FDA has just designated the recall as a 'Class I' alert, their most severe grade, which means the problem could cause serious harm or death.
The problem in all four devices revolves around defective foam or an assembly error that can cause the speaker in the devices to lose contact with the internal circuit board.
This can cause the wearable monitor to stop sounding an alarm when the user's blood sugar enters dangerous zones.
Over 38 million Americans have diabetes. Nearly 100 million American adults have prediabetes, according to data and estimates from the CDC.
This is a developing story. More updates to follow.
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