BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173334 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05149
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    June 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE SUBJECT PUMP WAS INVESTIGATED AND THE FOLLOWING WAS NOTED: THE "UP, DOWN, & OK" BUTTONS WERE NOT RESPONDING. MOISTURE RESIDUAL WAS LOCATED ON THE DISPLAY SCREEN. PRODUCT ANALYSIS PERFORMED LEAK TEST AND FOUND LEAKAGE FROM DISPLAY LENS. DISASSEMBLED THE PUMP AND FOUND MOISTURE RESIDUAL ON PCB AND SCREEN. REMOVED THE KEYPAD AND FOUND ADHESIVE AND CORROSION UNDER THE CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THE BUTTONS ARE ALL UNRESPONSIVE. PATIENT STATED HE SWAM WITH PUMP THIS MORNING AND NOW REPORTS 2-3 DROPS OF WATER UNDER DISPLAY. THE KEYPAD IS REPORTEDLY INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATE WITH THIS COMPLAINT. THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR