BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4090959 · Received September 15, 2014

    Report

    Report Number
    2531779-2014-26335
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/01/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE ALARM HISTORY SHOWS EVIDENCE OF FOUR CS-052-0001 ALARMS. AN EZPRIME SEQUENCE AND 24HR DURATION TEST WERE SUCCESSFULLY COMPLETED WITH NO CALL SERVICE ALARMS BEING DUPLICATED. REMOVED PUMP COVER; INTERNAL MOISTURE WAS OBSERVED ON THE PCB AND INTERNAL COMPONENTS. THE COMPLAINT WAS CONFIRMED IN THE PUMP HISTORY BUT NOT DUPLICATED DURING TESTING. RETURNED BATTERY CAP AND RETURNED CARTRIDGE CAP USED TO COMPLETE TESTING. 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 CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) 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
    568990 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR