BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1213520 · Received October 27, 2008

    Report

    Report Number
    2531779-2008-00727
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A CRACK IN THE BATTERY COMPARTMENT HOUSING, WHICH IS UNRELATED TO THE COMPLAINT. THE PUMP WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    PATIENT REPORTS HOSPITALIZATION, DUE TO LOW BLOOD SUGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization