BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1070920 · Received July 7, 2008

    Report

    Report Number
    2531779-2008-00374
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL CONFIRMED VISIBLE DAMAGED TO THE BATTERY COMPARTMENT AND BATTERY CAP AS WAS REPORTED TO HAVE OCCURRED SUBSEQUENT TO THE EVENT. EVAL ALSO DEMONSTRATED THAT PUMP INSULIN DELIVERY WAS OPERATING WITHIN REQUIRED SPECS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE PT RECEIVED EMERGENCY ROOM TREATMENT FOR HYPOGLYCEMIA. IT WAS ALSO REPORTED THAT SUBSEQUENT TO THE HYPOGLYCEMIC EVENT THE PUMP BATTERY HOUSING WAS FOUND TO BE DAMAGED AND THE BATTERY CAP COULD NOT BE PROPERLY TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP IR 1250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization