BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1881512 · Received October 19, 2010

    Report

    Report Number
    2531779-2010-01754
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE PUMP WAS UNRESPONSIVE TO DOWN ARROW BUTTON PRESSES. ALL OTHER KEYPAD BUTTONS WERE RESPONSIVE TO USER INPUTS. EVIDENCE OF MOISTURE CORROSION WAS OBSERVED UNDER ALL KEY CONTACTS. THE KEYPAD WAS FOUND TO BE TORN AND LIFTED BY THE OK BUTTON.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS NOT RESPONDING TO DOWN ARROW BUTTON PRESSES. THE REPORTER CLAIMED THAT THE BUTTON WAS NO LONGER SPRINGING BACK, BUT WAS CLICKING AS USUAL. THE KEYPAD WAS ALSO REPORTEDLY PEELING BY THE OK BUTTON. THE PT DENIED THAT THE DEVICE WAS 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 23 YR