BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1935481 · Received December 14, 2010

    Report

    Report Number
    2531779-2010-02874
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PT CLAIMED THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO DOWN ARROW BUTTON PRESSES. HE ALSO CLAIMED THAT THE BUTTON NEEDED TO BE PRESSED SEVERAL TIMES BEFORE THE PUMP WOULD RESPOND AND AT TIMES, THE BUTTON WOULD STICK. THE PT DENIED ANY TRAUMA TO THE KEYPAD. THE PT CLAIMED THAT THE KEYPAD WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1