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ANIMAS INSULIN INFUSION PUMP Adverse Event — Injury (MDR 2531779-2008-00100)

ANIMAS INSULIN INFUSION PUMP Adverse Event — Injury (MDR 2531779-2008-00100) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ANIMAS INSULIN INFUSION PUMP; Generic name: INSULIN INFUSION PUMP; Manufacturer: ANIMAS CORP..

DeviceANIMAS INSULIN INFUSION PUMP
Generic nameINSULIN INFUSION PUMP
ManufacturerANIMAS CORP.
Report number2531779-2008-00100
Event typeInjury
Product problemN
Date received2008-02-19
Report sourceConsumer
NarrativeTHE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PATIENT'S BLOOD GLUCOSE LEVELS REMAINED ELEVATED ON SUPPLEMENTAL INSULIN INJECTIONS AND THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. IF THE DEVICE IS RETURNE
SourceopenFDA MAUDE (device adverse events)

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