BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2433070 · Received January 31, 2012

    Report

    Report Number
    2531779-2012-00761
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Report Date
    October 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 2531779-03/24/2010-003-R. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR A LARGE PRIME VOLUME. DURING EVALUATION, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR