BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2210159 · Received August 12, 2011

    Report

    Report Number
    2531779-2011-05837
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS ARE UNRESPONSIVE; INVESTIGATORS WERE UNABLE TO MOVE THE PUMP BEYOND THE VERIFICATION SCREEN. EVALUATION REVEALED MOISTURE BEHIND THE DISPLAY LENS AND ON THE PCB, AND LEAK TESTING REVEALED A CASE SEAL LEAK. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP WAS STUCK ON THE VERIFY SCREEN AFTER THE PATIENT WENT SWIMMING; THE PATIENT WAS UNABLE TO OBTAIN A RESPONSE WITH KEYPAD BUTTON PRESSES. THE FAMILY MEMBER CONFIRMED THAT THE KEYPAD IS INTACT AND THAT THERE IS NO EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN OR IN THE BATTERY COMPARTMENT. SHE STATED THAT THE PATIENT WEARS THE PUMP IN HIS POCKET AND DOES NOT CLEAN THE PUMP.

    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 13 YR