BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1901605 · Received November 10, 2010

    Report

    Report Number
    2531779-2010-02201
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 10, 2010
    Manufacturer
    ANIMAS CORP.
    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 HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE PUMP WAS NOT RESPONDING TO UP KEYPAD BUTTON PRESSES. THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED. THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PT) CLAIMING THAT THE PUMP WAS NOT RESPONDING TO UP ARROW BUTTON PRESSES. SHE CLAIMED THAT THE KEYPAD WAS INTACT AND THAT THE PUMP WAS 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 9 YR