BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2780316 · Received October 10, 2012

    Report

    Report Number
    2531779-2012-12064
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE KEYPAD WAS FOUND TO BE PEELING. THE "UP" BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONDING. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. UNRELATED TO THE EVENT THE DISPLAY WAS FOUND TO BE DIM AND FADING AND THE BATTERY COMPARTMENT WAS CRACKED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE DOWN ARROW AND CONTRAST KEYPAD BUTTONS ARE INTERMITTENTLY UNRESPONSIVE. THE PATIENT CONFIRMED THAT THE KEYPAD IS INTACT AND THE PUMP HAS NOT BEEN EXPOSED TO WATER. THE PATIENT REPORTEDLY WEARS THE PUMP ON A BELT AND DOES NOT CLEAN THE PUMP. THERE IS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED KEYPAD MALFUNCTION REMAINED UNRESOLVED.

    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 32 YR