BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4823144 · Received June 6, 2015

    Report

    Report Number
    2531779-2015-18874
    Event Type
    Malfunction
    Date Received
    June 6, 2015
    Report Date
    May 27, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 09/25/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: THE REPORTED EVENT DATE OF (B)(6) 2015 WAS FOUND TO BE OVERWRITTEN IN THE BLACK BOX. BLACK BOX INDICATED MULTIPLE ¿CALL SERVICE (CS) 162¿ LOSS OF PRIME WARNINGS DUE TO LOW NON ZERO FORCE. THE RETURNED BATTERY/CARTRIDGE CAPS WERE USED DURING INVESTIGATION. THE ¿EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY ON THE PUMP. THERE WERE NO ¿CS162¿ WARNINGS OR ANY ERRORS, ALARMS OR WARNINGS THAT OCCURRED DURING THE INVESTIGATION. THE PRODUCT PERFORMED WITHIN SPECIFICATION AND THE REPORTED ¿LOSS OF PRIME¿ COMPLAINT WAS UNABLE TO BE DUPLICATED. 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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THE REPORTER ALLEGED THAT APPROXIMATELY 1 UNIT OF INSULIN WAS INFUSED. 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
    366909 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR