BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3943463 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20580
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/15/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED FROM THE THREADS TO THE BASE SEAL AND MOISTURE CORROSION WAS EVIDENT IN THE COMPARTMENT. A LEAK TEST SHOWED A LEAK WHERE THE CRACK WAS LOCATED. THE BATTERY CAP WAS DAMAGED AND A TEST CAP WAS USED IN THE EVALUATION. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. THE DISPLAY AND ALL THE KEYPAD BUTTONS FUNCTIONED PROPERLY. PUMP CASING WAS OPENED AND NO EVIDENCE OF MOISTURE INTRUSION WAS FOUND INSIDE THE PUMP.

    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 A CASING/CONDITION (MOISTURE INGRESS) ISSUE. REPORTEDLY, MOISTURE WAS OBSERVED IN THE BATTERY COMPARTMENT AND NO DAMAGE TO THE PUMP WAS NOTED. 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
    422650 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR