BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2151747 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04708
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION COMPLETED ON 06/08/2011. CORRECTION/REMOVAL REPORTING NUMBER: 2531779-03/24/2010-003-R. DURING EVALUATION, THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE PHYSICALLY DAMAGED AND THE FORCE SENSOR WAS OUT OF CALIBRATION.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIAMS. EVALUATION REVEALED THAT THE FORCE SENSOR ASSEMBLY WAS PHYSICALLY DAMAGED. 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 29 YR