BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7665497 · Received July 5, 2018

    Report

    Report Number
    2531779-2018-12366
    Event Type
    Malfunction
    Date Received
    July 5, 2018
    Report Date
    June 27, 2018
    Manufacturer
    ANIMAS LLC
    Product Code
    POY
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 17-JUL-2018 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED UP TO A FULLY FUNCTIONAL DISPLAY. THE ALLEGED LINE THROUGH THE DISPLAY WAS UNABLE TO BE DUPLICATED. VISIBLE MOISTURE WAS FOUND IN THE BATTERY COMPARTMENT WITH A LEAK. THE PUMP WAS OPENED TO FIND MOISTURE CORROSION ON THE BATTERY HOUSING. NO MOISTURE WAS FOUND ON THE DISPLAY.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (LINE THROUGH DISPLAY WITH MOISTURE) ISSUE. IT WAS ALLEGED THERE WAS MOISTURE BEHIND THE DISPLAY. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY IMPACT THE USER'S ABILITY TO READ SOME OR ALL OF THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507645 ANIMAS VIBE INSULIN INFUSION PUMP POY ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR