BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6174787 · Received December 15, 2016

    Report

    Report Number
    2531779-2016-33604
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Report Date
    November 17, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/17/2016 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DISPLAY WAS FOUND TO BE DIM AND DISCOLORED. UNRELATED TO THE ISSUE, THE AUDIO BOLUS BUTTON WAS MISSING. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE DISPLAY WAS DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 11/17/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830052 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1