BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1882492 · Received October 21, 2010

    Report

    Report Number
    2531779-2010-01773
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE DISPLAY SCREEN WAS FOUND TO BE UNRESPONSIVE. THE KEYPAD WAS FOUND TO BE LOOSE AND PEELING. THE PUMP WAS OPENED AND MOISTURE AND CORROSION WERE OBSERVED ON CIRCUIT BOARD ON THE DISPLAY AND THE KEYPAD FLEX CONNECTORS. A REVIEW OF THE PUMP HISTORY REVEALED NO EVIDENCE OF A 6 UNIT BOLUS BEING PROGRAMMED OR DELIVERED. THE PUMP WAS UNABLE TO BE FULLY INVESTIGATED TO THE UNRESPONSIVE SCREEN.

    Description of Event or Problem · 1

    THE PT REPORTED HEARING A CHIRP, LOOKING AT HIS PUMP AND SEEING THE NORMAL BOLUS SCREEN WITH 6.00 UNITS FLASHING. THE PT REPORTS CANCELLING THE BOLUS AS HE DID NOT WISH TO DELIVER IT. HE WEARS THE PUMP IN A LEATHER CASE CLIPPED TO HIS BELT AND REPORTS NOT BEING ON THE GROUND OR LEANING ON ANYTHING. HE REPORTS NO ISSUES WITH THE BUTTONS.

    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 59 YR