BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1931476 · Received December 8, 2010

    Report

    Report Number
    2531779-2010-02791
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: PUMP BOOTS UP TO 'VERIFY' SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. NO VISUAL/ DAMAGE OBSERVED TO KEYPAD. "CONTRAST BUTTON UNRESPONSIVE AND DOES NOT SPRING BACK WHEN PRESSED. 'UP/OK' BUTTONS WERE RESPONSIVE WHILE THE 'DOWN' BUTTON WAS INTERMITTENTLY RESPONSIVE; 'UP/DOWN/OK' BUTTONS SPRING BACK NORMALLY. DURING A VISUAL INSPECTION, THERE WAS CONTAMINATION OBSERVED UNDER 'DOWN/CONTRAST' BUTTONS AND NO CONTAMINATION OBSERVED UNDER 'UP/OK' BUTTONS.

    Description of Event or Problem · 1

    THE LAY-USER/PT ALLEGED THAT THE BUTTONS ON THE KEYPAD DO NOT RESPOND. THERE WAS PRODUCT MISUSE. THE KEYPAD DID NOT APPEAR TO BE PEELED OR TORN. FURTHERMORE, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1