Deaths and injuries: Dramatic error in blood glucose sensors, diabetics advised to check their devices immediately

We have reported a number of times on CGM systems for blood glucose monitoring, including on severe connection problems that can pose a significant risk to patient health. Communication between such CGM systems and smartphones does not always run as smoothly as it should and as one would expect from an expensive medical device. The FDA has now issued a warning over the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.

These sensors may display glucose levels that are too low. As a result, patients may inject too little insulin or consume too many carbohydrates. According to the FDA warning, this error has already been linked to 736 injuries and even 7 deaths. We want to stress the importance of the term "link" here, as it remains unclear whether this is a single cause, or whether this error may have worsened the outcome of another illness or injury not necessarily directly related to diabetes. Generally speaking, elevated blood sugar levels tend to lead to more long-term complications as opposed to hypoglycemia, which can quickly lead to hypoglycemic shock with loss of consciousness and can be fatal if left untreated. Nevertheless, the possibility of hyperglycemic shock should also be kept in mind.

Users of the aforementioned senors should immediately check the serial number of the sensors they are using and request replacement sensors if necessary.