BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2183115 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05407
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    March 24, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL # 2531779-03/24/2010/003-R. THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED ON (B)(4) 2011. EVALUATION REVEALED A DAMAGED FORCE SENSOR SHIM SPOKE. THE PUMP WAS REWOUND, LOADED, PRIMED, AND EXERCISED WITH NO ALARMS OCCURRING. REVIEW OF THE PUMP HISTORY REVEALS LOSS OF PRIME WARNINGS ASSOCIATED WITH LOW FORCE. THE FORCE SENSOR CALIBRATION CHECK PASSED. THE CARTRIDGE WAS ALSO RETURNED TO ANIMAS. THE CARTRIDGE PASSES VISUAL INSPECTION AND A FORCE TEST WAS PERFORMED WITH NO FAILURES OCCURRING.

    Description of Event or Problem · 1

    EVALUATION REVEALED THAT THE FORCE SENSOR SPOKE SHIM WAS DAMAGED.

    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 7 YR