BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173433 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05156
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS N RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE SUBJECT PUMP WAS INVESTIGATED WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE KEYPAD. ALL THE KEYS INTERMITTENTLY STICK CAUSING SCROLLING. PRODUCT ANALYSIS (PA) OBSERVED DAMAGE TO THE KEYPAD. PA REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS AND NOTICED THAT CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT OK BUTTON IS NOT WORKING AND WHEN PRESSING THE OK BUTTON IT TAKES THE PATIENT TO ANOTHER SCREEN. THE KEYPAD IS REPORTEDLY INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATE WITH THIS COMPLAINT. THE PUMP WAS REPLACED.

    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 16 YR