BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3974706 · Received August 3, 2014

    Report

    Report Number
    2531779-2014-22156
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Report Date
    July 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/03/2014 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. A TEST BATTERY CAP WAS USED TO COMPLETE THE INVESTIGATION. MOISTURE WAS FOUND TO BE BEHIND THE DISPLAY SCREEN. THE DISPLAY LENS WAS FOUND TO HAVE A LEAK PRESENT. THERE WAS EVIDENCE OF MOISTURE INSIDE ALL OF THE INTERNAL PUMP COMPONENTS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THERE WAS MOISTURE BEHIND THE DISPLAY SCREEN. 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
    452582 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR