BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2162355 · Received July 14, 2011

    Report

    Report Number
    2531779-2011-04952
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON 06/17/2011. (B)(6). RECALL 2531779-03/24/2010-003-R. DURING EVALUATION THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE PHYSICALLY DAMAGED.

    Description of Event or Problem · 1

    PUMP IS RETURNED FOR MULTIPLE LOSS OF PRIME ALARMS. EVALUATION REVEALED A DAMAGED FORCE SENSOR ASSEMBLY. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR