BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4192478 · Received October 22, 2014

    Report

    Report Number
    2531779-2014-29961
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: - DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/05/2014 WITH THE FOLLOWING FINDINGS: NO POWER ISSUES WERE OBSERVED IN THE BLACK BOX HISTORY. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT. THE THREADS ON THE BATTERY CAP WERE OBSERVED TO BE STRIPPED AND THE BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION. A POWER LOSS AND PUMP REBOOTS WERE DUPLICATED. A TEST CAP WAS USED TO COMPLETE THE INVESTIGATION. THE PUMP POWERED ON NORMALLY WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE TEST CAP WITH NO FURTHER POWER ISSUES OCCURRING. UNRELATED TO THE POWER ISSUES, THE DISPLAY WAS DIM AND DISCOLORED. 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.

    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 REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE BATTERY CAP HAD STRIPPED THREADS. 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
    671560 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR