BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4920686 · Received July 17, 2015

    Report

    Report Number
    2531779-2015-24154
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Report Date
    July 1, 2015
    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 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 SUBMITTED: 09/17/2015. THE PUMP WAS RETURNED TO THE MANUFACTURER AND INVESTIGATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA AND DOWNLOAD HISTORY REVEALED MULTIPLE UNEXPLAINED ¿POWER ON RESET¿ RECORDED IN THE BLACK BOX HISTORY. THE RETURNED BATTERY CAP RETURNED WITH THE PUMP HAD DAMAGED THREADS (STRIPPED/TORN) AND WAS UNABLE TO MAINTAIN ELECTRICAL CONTACT; THE PUMP CONTINUALLY REBOOTS WITH THIS CAP IN PLACE. THE RETURNED CAP DOES NOT TIGHTEN/THREAD ON A TEST PUMP. BATTERY CAP CONTACT WIDTH AND CONTACT HEIGHT WERE MEASURED AND FOUND TO BE OUT OF TOLERANCE. THE BATTERY COMPARTMENT WAS CRACKED AT THE BATTERY COMPARTMENT THREADS ABOVE THE BUMPER. USING A TEST BATTERY CAP, THE PUMP WAS EXERCISED AND WAS ABLE TO RUN ON A 24 HOUR BASAL PROGRAM WITHOUT INTERMITTENT POWER OR REBOOTING. THE PUMP WAS OPENED FOR INVESTIGATION; THE POWER CIRCUIT WAS EVALUATED AND FOUND TO BE WITHOUT DEFECT. THERE WAS NO MOISTURE INSIDE THE PUMP. INVESTIGATION DUPLICATED THE ALLEGED POWER ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE; STRIPPED THREADS ON 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
    465532 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR