BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS INSTRUMENT

    MDR report key: 592128 · Received April 8, 2005

    Report

    Report Number
    3002769706-2005-00013
    Event Type
    Malfunction
    Date Received
    April 8, 2005
    Date of Event
    March 10, 2005
    Report Date
    April 8, 2005
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A FALSE VALUE WAS REPORTED ON THE VIDAS DIGOXIN ASSAY. THE FALSE RESULTS WAS DUE TO A PUMP SEAL INCORRECTLY POSITIONED THUS CAUSING A PIPETTING ERROR. THE PATIENT WAS ALREADY ON DIGOXIN THERAPY AND THE INCORRECT RESULT DID NOT AFFECT OR ALTER THE PATIENT'S THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIDAS INSTRUMENT DISCRETE WAVELENGTH FLUROMETER JZT BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other