BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1193147 · Received October 7, 2008

    Report

    Report Number
    2531779-2008-00677
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 7, 2008
    Report Date
    September 7, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED AN INTERMITTENT LOSS OF CONTACT BETWEEN THE BATTERY CAP AND THE PUMP CASE.

    Description of Event or Problem · 1

    PATIENT REPORTS THE PUMP IS RESETTING ITSELF WITHOUT USER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1200

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR