BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6130891 · Received November 28, 2016

    Report

    Report Number
    2531779-2016-32307
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Report Date
    November 2, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    MDS
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1: DATE OF SUBMISSION: 1/06/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/16/2016 WITH THE FOLLOWING FINDINGS: DURING VISUAL INSPECTION OF THE PUMP, IT WAS OBSERVED THAT THE PUMP WAS RETURNED WITH A DIM AND DISCOLORED DISPLAY. UNRELATED TO THE INITIAL COMPLAINT, IT WAS OBSERVED THAT THE AUDIO BOLUS BUTTON COVER WAS DAMAGED BUT THE BOLUS BUTTON WAS RESPONSIVE DURING THE INVESTIGATION. THE BATTERY CAP AND CARTRIDGE CAP WERE NOT RETURNED WITH THE PUMP AND A TEST CAP WAS USED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. 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. 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
    781118 ANIMAS VIBE INSULIN INFUSION PUMP MDS ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1