BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4956272 · Received July 31, 2015

    Report

    Report Number
    2531779-2015-26377
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    July 13, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 9/28/15 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. LAST BASAL DELIVERY WAS ON (B)(6) 2015@11:51AM, LAST BOLUS DELIVERY WAS ON 06/09/15@2:29PM. TDD ADD UP CORRECTLY AND REFLECT THE PROGRAMMED BASAL RATE TARGET. REVIEW OF THE PUMPS USER SETTINGS SHOWS DELIVERY SPEED SET TO ¿NORMAL¿.2-¿EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY, THE PUMP REFLECTED 24U AFTER A 24HR ON 1U/HR BASAL PROGRAM DURATION TEST, NO ¿DELIVERY INTERRUPTION OCCURRED. TEST BOLUSES WERE DELIVERED NORMALLY. THE PRODUCT PERFORMS WITHIN SPEC UNABLE TO DUPLICATE ¿DELIVERY SPEED TOO FAST¿ COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE REPORTER CONTACTED ANIMAS, ALLEGING A THAT THE "INJECTION" SPEED OF THE PUMP IS TOO FAST. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500013 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR