BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070541 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02028
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE UP AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. DURING INVESTIGATION, THE UP AND DOWN ARROW KEY CONTACTS WERE OBSERVED TO BE MISALIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOWN ARROW REQUIRES MULTIPLE PRESSES FOR A RESPONSE. IT WAS REPORTED THAT THE RUBBER IS INTACT AND THE PUMP IS NOT EXPOSED TO MOISTURE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1