BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2183037 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05406
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RECALL #: 2531779-03/24/2010/003-R. THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. THE PUMP WAS REWOUND, LOADED, PRIMED, AND EXERCISED WITH NO ALARMS OCCURRING. REVIEW OF THE PUMP HISTORY REVEALS TWO LOSS OF PRIME WARNINGS ASSOCIATED WITH ZERO FORCE AND TWO "NO CARTRIDGE DETECTED" WARNINGS. THE CARTRIDGE WAS ALSO RETURNED TO ANIMAS AND PASSES VISUAL INSPECTION. A FORCE TEST WAS PERFORMED ON THE CARTRIDGE WITH NO FAILURES OCCURRING.

    Description of Event or Problem · 1

    EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.

    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 19 YR