BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4101388 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26798
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 6, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/31/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS WITH RETURNED BATTERY CAP TO A DIM DISCOLORED DISPLAY. BATTERY CAP ABLE TO FULLY TIGHTEN. THE BATTERY CAP MEASURES WITHIN SPECIFICATIONS. THE BATTERY COMPARTMENT WAS CRACKED OBSERVED BELOW GRIP PAD. UNEXPLAINABLE POWER ON RESET (POR) EVENTS OBSERVED IN BLACK BOX ON (B)(6) 2014 AND (B)(6) 2014. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. NO "INTERMITTENT POWER" EVENTS DUPLICATED DURING INVESTIGATION. REMOVED PUMP CASE. EVIDENCE OF 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 (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
    582056 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR