BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4133821 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28062
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: DATE OF SUBMISSION 12/09/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/20/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP. THE BATTERY CAP WAS UNABLE TO FULLY TIGHTEN BUT WAS CRACKED AND THE THREADS WERE DAMAGED. A POWER LOSS WAS NOT DUPLICATED. THE BATTERY COMPARTMENT WAS CRACKED BELOW THE GRIP PAD. PUMP REBOOT EVENTS WERE OBSERVED IN BLACK BOX ON 9/19/2014. PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. NO "INTERMITTENT POWER" EVENTS DUPLICATED DURING INVESTIGATION. THERE WAS NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS INSIDE THE PUMP. UNRELEATED TO THE POWER ALLEGATIONS, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) 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
    611586 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR