BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 335400 · Received May 24, 2001

    Report

    Report Number
    1950204-2001-00009
    Event Type
    Malfunction
    Date Received
    May 24, 2001
    Date of Event
    March 19, 2001
    Report Date
    May 22, 2001
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THEY WERE HAVING PROBLEMS WITH PATIENT RESULTS. A FIELD SERVICE ENGINEER WAS SENT TO THE SITE AT WHICH TIME THE INSTRUMENT FAILED A PUMP DIAGNOSTIC TEST (OCT TEST). THE PUMP WAS REPLACED AND THE OLD PUMP WAS CONFIRMED TO HAVE A CLOGGED PUMP TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24400 VIDAS IMMUNOFLUROMETRIC EQUIPMENT JZT BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *