BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2071091 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02928
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE OK BUTTON DOES NOT CLICK OR SPRING BACK NORMALLY AND WAS MISALIGNED. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY 0 UNIT BOLUS DOSES DELIVERED WITHOUT BUTTON PRESSES.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SEVERAL TIMES HER PUMP WOULD VIBRATE, AND WHEN SHE WOULD LOOK AT THE SCREEN NOTICED A 0.000 UNIT BOLUS BEING DELIVERED. THIS OCCURRED MULTIPLE TIMES THROUGHOUT THE DAY. SHE THOUGHT AT FIRST IT WAS OCCURRING BECAUSE SHE WAS WEARING PUMP IN HER BRA SO SHE MOVED THE PUMP AND CLIPPED THE PUMP TO HER PANTS AWAY FROM HER SKIN. SHE REPORTS THAT EVEN AFTER MOVING PUMP THE PUMP CONTINUED TO DELIVER 0 UNIT BOLUS DOSES WITHOUT BUTTON PRESSES. THE PUMP HISTORY REVEALED 0.000 UNIT BOLUS DOSES DELIVERED MULTIPLE TIMES WITHIN ONE HOUR ON THE SAME DAY. THE PATIENT ALSO REPORTS THAT THE OK BUTTON NO LONGER CLICKS AND SPRINGS BACK LIKE IT SHOULD. SHE STATES THIS PROBLEM STARTED SEVERAL DAYS AGO. THE PATIENT DENIED ANY PHYSICAL DAMAGE TO THE KEYPAD AND DENIED ANY TRAUMA TO THE PUMP OR EXPOSURE TO MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR