BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3960003 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21545
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 18, 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 09/08/2014 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP, SO ALL TESTING WAS COMPLETED WITH A TEST BATTERY CAP. THE TEST CAP WAS UNABLE TO FULLY TIGHTEN. THE BATTERY COMPARTMENT THREADS WERE DAMAGED AND THE COMPARTMENT WAS CRACKED. THERE WAS ONE UNEXPLAINABLE PUMP REBOOT OBSERVED IN THE BLACK BOX HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOTS, NO LOSS OF POWER AND NO CALL SERVICE ALARMS DUPLICATED. THERE WAS NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS INSIDE THE PUMP WHEN THE CASE WAS REMOVED.

    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 POWER (DAMAGE) ISSUE. IT WAS ALLEGED THAT THE PUMP WAS EXPERIENCING AN INTERMITTENT POWER ISSUE AND THAT THE BATTERY COMPARTMENT WAS CRACKED. 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
    439268 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR