BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5980476 · Received September 27, 2016

    Report

    Report Number
    2531779-2016-26959
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Report Date
    September 3, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100228
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/13/2016 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS POWERED ON TO A CLEAR AND LEGIBLE DISPLAY. THE PUMP WAS OPENED TO FIND THE DISPLAY FEX FULLY SEATED AND SECURE IN THE CONNECTOR. THE ORIGINAL COMPLAINT OF A LINE IN THE DISPLAY WAS UNABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS A LINE THROUGH 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
    633594 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100228

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR