BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173068 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05145
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED AND TESTED WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE KEYPAD. MULTIPLE BUTTON PRESSES ARE REQUIRED BEFORE THE BUTTONS WILL ENGAGE. PRODUCT ANALYSIS REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT THE KEYPAD IS WORN OUT AND ALL BUTTONS NEED TO BE PRESSED SEVERAL TIMES BEFORE THEY FUNCTIONED PROPERLY. MOTHER ALSO MENTIONED THAT THE SCREEN WAS DIM AND HAS NOTICED IT GRADUALLY GETTING DIMMER OVER TIME. 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 8 YR