BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3885347 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17701
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 08/22/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/30/2015 WITH THE FOLLOWING FINDINGS:THE PUMP WAS RETURNED WITH VISIBLE MOISTURE BEHIND THE DISPLAY LENS. A PUMP LEAK TEST CONFIRMED THE PUMP WAS LEAKING DUE TO DAMAGE TO THE BATTERY COMPARTMENT. THE PUMP POWERED ON TO A BLANK SCREEN. FULL TESTING WAS UNABLE TO BE COMPLETED DUE TO THE INTERNAL MOISTURE. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND THROUGHOUT THE INSIDE OF THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE WOULD NOT POWER ON WITH THE LITHIUM BATTERY WHEN INSERTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360717 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR