BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2151841 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04723
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION AND EVALUATED. CONFIRMED THE BOLUS BUTTON IS NOT RESPONDING TO BUTTON PRESSES. BOLUS BUTTON COVER WAS REMOVED TO INVESTIGATE AND IT WAS NOTED THAT THE INTERNAL PLUG IS MISSING. TESTING CONFIRMED ALL BUTTONS ON THE KEYPAD ARE RESPONSIVE TO BUTTON PRESSES AND ARE FUNCTIONAL. THE KEYPAD HAS NO VISIBLE SIGN OF DAMAGE. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS AND NO ISSUES FOUND.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THE BOLUS BUTTON DOES NOT WORK, EVEN AFTER SEVERAL PRESSES. 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 5 YR