BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4112334 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27224
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/03/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS WITH RETURNED BATTERY CAP. BATTERY CAP IS ABLE TO FULLY TIGHTEN. A POWER LOSS WAS NOT DUPLICATED. THE BATTERY COMPARTMENT WAS INTACT. THE BLACK BOX DATES FROM (B)(6) 2014. NO "NO POWER" EVENTS OBSERVED IN BLACK BOX. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. NO "NO POWER" EVENTS DUPLICATED DURING INVESTIGATION. THERE WAS NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS INSIDE PUMP. THERE WAS NO DEFECT FOUND.

    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 (NO 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
    592300 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR