Public recall detail

Archived - Recall of D-TRONplus Insulin Pump Power Packs - Disetronic Medical Systems, Inc.

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Quick summary: Archived - Recall of D-TRONplus Insulin Pump Power Packs - Disetronic Medical Systems, Inc. .

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Recall details

Quick summary: Archived - Recall of D-TRONplus Insulin Pump Power Packs - Disetronic Medical Systems, Inc. .

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Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

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Issue

Disetronic is conducting this recall of Disetronic D-TRONplus Power Packs because the power packs for the D-TRONplus insulin pumps have a potential to shut down the pump without warning. The battery's design was changed by its manufacturer. As a result, the pump does not have enough time to recognize the power supply decrease, and the pump may shut down before the audible and vibrating low power alarms are triggered. This can lead to an interruption of insulin delivery, which may lead to uncontrolled diabetes mellitus, resulting in elevated blood glucose levels (hyperglycemia). In the event that insulin delivery is interrupted, it is possible that patients may experience adverse events, which may result in serious patient injury and/or death. Adverse events may range from nausea and vomiting to diabetic ketoacidosis and coma.

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Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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