BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 340537 · Received June 28, 2001

    Report

    Report Number
    1950204-2001-00010
    Event Type
    Malfunction
    Date Received
    June 28, 2001
    Date of Event
    June 13, 2001
    Report Date
    June 28, 2001
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED THE COMPANY WITH A SINGLE INCORRECT ASSAY RESULT. FURTHER INVESTIGATION REVEALED THAT POSITION D4 GAVE FOUR FALSE RESULTS, TWO FALSE POSITIVES, TWO FALSE NEGATIVES. NO FALSE RESULTS WERE REPORTED TO THE PT AS ALL FALSE RESULTS WERE DETECTED BY RETEST PRIOR TO REPORTING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29261 VIDAS IMMUNOFLUROMETRIC EQUIPMENT JZT BIOMERIEUX, INC. VIDAS 30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *