BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3875070 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17136
    Event Type
    Malfunction
    Date Received
    June 16, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/14/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BATTERY CAP HAS DAMAGED THREADS. THE BATTERY CAP WAS WITHIN SPECIFICATIONS. ALL TESTING PERFORMED WITH A TEST BATTERY CAP. THE PUMP IS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION WITH RETURNED BATTERY CAP DUE TO CAP DETACHING. BATTERY COMPARTMENT CRACKS WERE OBSERVED IN THREAD AREA AND BELOW GRIP PAD. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION ON UNDERSIDE OF BATTERY CAP. THE BLACK BOX SHOWS MULTIPLE UNEXPLAINABLE POWER ON RESET EVENTS ON (B)(6) 2014. THE PUMP WAS EXERCISED WITH A TEST CAP FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. REMOVED PUMP CASE. NO EVIDENCE OF ADDITIONAL MOISTURE CONTAMINATION INSIDE PUMP. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. 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
    353341 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR