BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1900050 · Received November 8, 2010

    Report

    Report Number
    2531779-2010-02191
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 9, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE PUMP DID NOT RESPOND TO PRESSES OF THE AUDIO BOLUS BUTTON. THE AUDIO BOLUS BUTTON WAS FOUND TO BE MISALIGNED. THE PUMP WAS INTERMITTENTLY RESPONDING TO PRESSES OF ALL BUTTONS. THE "OK" BUTTON CONTACT WAS ALSO MISALIGNED AND ADHESIVE WAS FOUND UNDER ALL BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE PUMP WAS NOT RESPONDING TO KEYPAD BUTTON PRESSES. SHE WAS UNABLE TO CONFIRM THE VERIFY SCREEN AS THE "UP," "DOWN," AND "OK" BUTTONS REPORTEDLY DID NOT FUNCTION. THE PT ALSO REPORTED THAT THE KEYPAD WAS PEELING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR