BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2050425 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02281
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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. EVALUATION CONFIRMED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. INVESTIGATION REVEALED THAT THE UP ARROW AND DOWN ARROW BUTTON KEY CONTACTS WERE MISALIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE UP ARROW AND DOWN ARROW BUTTONS BECAME INTERMITTENTLY UNRESPONSIVE THIS EVENING, AND REQUIRE SEVERAL PRESSES TO OBTAIN A RESPONSE. HE NOTED THAT THE BUTTONS FEEL HARD WHEN PRESSED. THE PATIENT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT HE WEARS THE PUMP IN HIS POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR