BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3922699 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19432
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/20/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. MOISTURE WAS EVIDENT IN THE BATTERY COMPARTMENT. THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A LEAK TEST SHOWED A LEAK IN THE BATTERY COMPARTMENT. PUMP CASING WAS OPENED AND NO ADDITIONAL EVIDENCE OF MOISTURE INTRUSION WAS FOUND INSIDE THE PUMP. THE REPORTED MOISTURE INGRESS ISSUE WAS VERIFIED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(4) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT MOISTURE WAS OBSERVED IN THE BATTERY COMPARTMENT. 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
    401719 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR