BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1163308 · Received September 9, 2008

    Report

    Report Number
    2531779-2008-00568
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    AN ANIMAS CLINICAL REPRESENTATIVE 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. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR