BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6092243 · Received November 10, 2016

    Report

    Report Number
    2531779-2016-31127
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    October 24, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: 12/28/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/12/2016 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH A BLANK DISPLAY. THE PUMP WAS OPENED AND THE DISPLAY SCREEN WAS FOUND TO BE CRACKED; A TEST DISPLAY WAS USED AND OPERATED PROPERLY. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED.

    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).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. 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
    743405 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1