BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1190735 · Received October 6, 2008

    Report

    Report Number
    2531779-2008-00671
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IT WAS DETERMINED THAT THE PUMP HAD 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. IR1250

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR