BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8821890 · Received July 24, 2019

    Report

    Report Number
    2531779-2019-04165
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Report Date
    July 19, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    UDI-DI
    10840406103168
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 09-SEPT-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS POWERED ON AND THE DISPLAY WAS FOUND TO BE BLANK WITH NORMAL AUDIBLE TONE AND VIBRATION. THE ORIGINAL COMPLAINT OF A DIM/FADING/COLOR SPECTRUM ISSUE WAS UNABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE BLANK DISPLAY. THE UNRELATED BLANK DISPLAY ISSUE WAS REPORTED IN ANIMAS MEDWATCH NUMBER 2531779-2019-04160. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE 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 THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616352 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC 10840406103168

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR