BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5401323 · Received February 1, 2016

    Report

    Report Number
    2531779-2016-03009
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Report Date
    January 13, 2016
    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: DATE OF SUBMISSION 03/14/2106 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX (BB) DATA REVEALED NO INDICATION OF POWER LOSS ON THE COMPLAINT DATE OF (B)(4) 2016. THERE WERE NO POWER ON RESET EVENTS (POR) RECORDED IN THE BB HISTORY. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT OR BATTERY CAP. THE BATTERY CAP WAS ABLE TO SECURE TIGHTLY TO THE PUMP. THE PUMP WAS RUN ON A 24 HOUR BASAL PROGRAM USING THE RETURNED BATTERY CAP WITH NO POWER LOSS OR REBOOT OCCURRENCES. THE PUMP WAS OPENED; THERE WERE NO DEFECTS FOUND TO THE POWER CIRCUIT AND NO INTERNAL MOISTURE WAS FOUND. THE REPORTED, ¿NO POWER¿ COMPLAINT, WAS NOT DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON 01/13/2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE FOR THIS COMPLAINT. 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
    59947 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1