BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1171967 · Received September 18, 2008

    Report

    Report Number
    2531779-2008-00596
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE PUMP EXHIBITED AN INTERMITTENT LOSS OF CONTACT BETWEEN THE BATTERY CAP AND THE PUMP CASE.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE PUMP WAS RESETTING ITSELF WITHOUT INTERVENTION WHEN USING THE ORIGINAL BATTERY CAP, AND THAT THE PUMP FUNCTIONED PROPERLY WHEN THE BATTERY CAP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR