BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1926065 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02449
    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 EVAL REVEALED THAT 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 THE "DOWN" AND "OK" CONTACTS WERE MISALIGNED. ALL OF THE KEY CONTACTS WERE INVERTED AND DID NOT ALWAYS SPRING BACK. THERE WAS ALSO EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE KEYPAD WAS INTERMITTENTLY RESPONDING. THE PT REPORTED THAT THE "OK" BUTTON WAS SLOW TO RESPOND AND HAD TO BE PRESSED MULTIPLE TIMES TO ELICIT A RESPONSE FROM THE KEYPAD. THE OTHER BUTTONS WERE RESPONDING BUT SLOWER THAN USUAL. THE RPTR DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO MOISTURE AND CLEANING SOLVENTS.

    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 15 YR