BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1070918 · Received July 7, 2008

    Report

    Report Number
    2531779-2008-00377
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A VISIBLE CRACK IN THE BATTERY HOUSING AND A DAMAGED BATTERY CAP THAT COULD NOT BE PROPERLY ATTACHED, AS REPORTED IN THE COMPLAINT. EVAL ALSO DEMONSTRATED THAT PUMP INSULIN DELIVERY WAS OPERATING WITHIN REQUIRED SPECS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE PT RECEIVED EMS TREATMENT FOR HYPOGLYCEMIA. THE PT ALSO REPORTED THAT THE PUMP EXHIBITED A VISIBLE CRACK IN THE BATTERY HOUSING AND A BATTERY CAP THAT COULD NOT BE PROPERLY ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention