BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4943843 · Received July 27, 2015

    Report

    Report Number
    2531779-2015-25642
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Report Date
    July 7, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/29/2015 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION, THE ALLEGED MOTOR ISSUE WAS NOT VERIFIED IN THE BLACK BOX OR DUPLICATED IN THE EVALUATION. REVIEW OF BLACK BOX DATA DID NOT FIND ANY MOTOR ALARMS OR ANY ACTIVITIES OUTSIDE OF NORMAL USE. USING THE RETURNED CAPS, THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR BASAL EXERCISE WERE EXECUTED WITHOUT ENCOUNTERING ANY UNUSUAL MOTOR NOISE OR ALARMS. PUMP CASING WAS OPENED AND NO INTERMITTENT CONDITIONS WERE FOUND ON THE MOTOR ASSEMBLY OR THE CONNECTOR WIRE. UNRELATED TO THE COMPLAINT, A BATTERY COMPARTMENT CRACK WAS FOUND ON THE SIDE OF THE COMPARTMENT RUNNING FROM THE THREADS TO THE CASE SEAL. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A MOTOR (MOTOR ISSUE) ISSUE. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE NATURE OF THE MOTOR 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
    487878 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1