Tandem Diabetes Care (Nasdaq: TNDM) issued an urgent medical device correction for certain t:slim X2 automated insulin pumps due to a potential speaker failure risk.
The pump software continuously monitors the electrical current through the speaker to ensure proper function. If current measurements fall outside a preset range, the pump declares a “Malfunction 16,” indicating speaker failure. When this occurs, insulin delivery stops, and the pump becomes non-operational.
If uncorrected, this malfunction may lead to hyperglycemia, requiring hospitalization or medical intervention.
Users are advised to monitor pump alerts closely and contact Tandem Diabetes Care for support if Malfunction 16 appears.
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