BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1172405 · Received September 19, 2008

    Report

    Report Number
    2531779-2008-00607
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A DAMAGED TRACE IN THE POWER CIRCUIT.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE PUMP WAS RESETTING ITSELF WITHOUT INTERVENTION.

    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 12 YR