BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3210963 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09792
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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.

    Additional Manufacturer Narrative · 1

    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. DEVICE EVALUATION: ON EXAMINATION, THERE WAS VISIBLE MOISTURE BEHIND THE DISPLAY LENS. THE PUMP WAS POWERED ON AND THE DISPLAY WAS ILLEGIBLE. THE PUMP DID NOT DEMONSTRATE VIBRATORY FUNCTION WHEN POWERED ON. A LEAK TEST WAS PERFORMED AND REVEALED A BATTERY COMPARTMENT LEAK AND A DISPLAY LENS LEAK. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED INTERNAL MOISTURE DAMAGE TO THE INTERNAL COMPONENTS AND THE PRINTED CIRCUIT BOARD. THERE WAS CORROSION ON THE VIBRATION MOTOR. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS AND REPORTED AN UNRESPONSIVE KEYPAD. THE PATIENT REPORTEDLY RECEIVED NOTIFICATION FROM THE PUMP INDICATING A DEAD BATTERY AFTER THE PATIENT WENT SWIMMING. THE BATTERY REPORTEDLY WAS REPLACED AND THE PATIENT WAS UNABLE TO GET PASSED THE VERIFICATION SCREEN OR SELECT ANYTHING ELSE USING THE KEYPAD BUTTONS. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309686 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR