CLEVELAND, Ohio – San Diego-based Tandem Diabetes Care Inc. announced a “medical device correction” for t:slim X2 insulin pumps.

A forthcoming software correction will address a potential speaker-related issue that can trigger an error resulting in discontinuation of insulin delivery.

The error appears as a Malfunction 16 alarm – an error code - to the user. It will stop insulin delivery and end communication between the pump and continuous glucose-monitoring device. If not addressed, this could result in hyperglycemia.

In severe cases of hyperglycemia, the user may require hospitalization. There have been 700 confirmed adverse events, defined as a confirmed high blood sugar and/or an event requiring medical intervention, 59 reported injuries and no deaths.

Details, including a searcha

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