BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3954569 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21224
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/16/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED CONSECUTIVE CALL SERVICE 012 ALARMS ON (B)(6) 2014. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION; A TEST BATTERY CAP AND THE RETURNED CARTRIDGE CAP WERE USED TO COMPLETE TESTING. THE PUMP SUCCESSFULLY COMPLETED EZ-PRIME STEPS AND A 24 HOUR EXERCISE TEST WITH NO ALARMS OCCURRING. THE PUMP PERFORMED WITHIN SPECIFICATIONS; THE COMPLAINT COULD NOT BE DUPLICATED ON INVESTIGATION. THE PUMP COVER WAS REMOVED AND THERE WERE NO DEFECTS FOUND TO THE PCB OR TO THE CGM MODULE. 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 012) 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
    434234 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1