BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3486066 · Received November 25, 2013

    Report

    Report Number
    2531779-2013-21972
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Report Date
    November 15, 2013
    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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/20/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX AND ALARM HISTORY SHOWS NO EVIDENCE OF CS 004-0001. THE PUMP BOOTS TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY SOUNDS. AN ¿EZPRIME¿ SEQUENCE WAS SUCCESSFULLY COMPLETED. THE PUMP WAS EXERCISED FOR 24HOURS DURATION PERIOD; NO CALL SERVICE ALARMS WERE DUPLICATED. REMOVED THE PUMP COVER; NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE PCB WAS OBSERVED. INVESTIGATORS WERE UNABLE TO DUPLICATE THE REPORTED COMPLAINT. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) 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
    614341 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR