BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2083421 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03300
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS NOT DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    PUMP IS RETURNED FOR MULTIPLE LOSS OF PRIME ALARMS. EVALUATION REVEALED PARTIALLY DISLODGED FORCE SENSOR PINS. 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 13