BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1926026 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02455
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING. ALL OF THE KEYPAD BUTTONS WERE INTERMITTENTLY RESPONDING AND REQUIRED EXCESSIVE FORCE TO ACTIVATE. THE KEYPAD WAS REMOVED AND THERE WAS EVIDENCE OF KEYPAD ADHESIVE UNDER KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE KEYPAD BUTTONS WERE NOT RESPONDING CORRECTLY. THE NUMBERS WOULD NOT SCROLL, BUT WHEN THE DESIRED BOLUS AMOUNT WAS PROGRAMMED, THEY WOULD APPEAR FOR A SHORT TIME. THE NUMBERS WOULD THEN CONTINUE TO EITHER INCREASE OR DECREASE EVEN AFTER THE BUTTONS WERE NOT PRESSED DEPENDING ON WHICH ARROW BUTTONS WERE PRESSED CAUSING THE INCORRECT BOLUS AMOUNT. THE RPTR DENIES DAMAGE TO THE KEYPAD AND THE BUTTONS DID NOT STICK.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR