BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2110463 · Received April 25, 2011

    Report

    Report Number
    2531779-2011-02801
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. ALL KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS DURING TESTING. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. DURING EVAL, THE BOLUS BUTTON WAS FOUND TO BE MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD IS RESPONDING INTERMITTENTLY OVER THE PAST 2 MONTHS. IT WAS REPORTED THAT THE PUMP DOES NOT GET WET AND THERE IS NO DAMAGE TO THE KEYPAD. THE PT CONTINUES TO USE THE PUMP.

    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