BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 335479 · Received May 24, 2001

    Report

    Report Number
    1950204-2001-00006
    Event Type
    Malfunction
    Date Received
    May 24, 2001
    Date of Event
    March 12, 2001
    Report Date
    May 21, 2001
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    JZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER IN ITALY CALLED TO REPORT THAT THEY WERE RECEIVING INCORRECT RESULTS AS THE RFV VALUES WERE NEAR ZERO IN POSITION A2 ON THE INSTRUMENT. CUSTOMER IMMEDIATELY PLACED SECTION A OFFLINE AND FIELD SERVICE WAS DISPATCHED. THE PUMP WAS SUBSEQUENTLY REPLACED BY FIELD SERVICE AND THE SECTION WAS PLACED BACK IN SERVICE. THE CUSTOMER DOES NOT BELIEVE ANY PATIENT RESULTS WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24170 VIDAS IMMUNOFLUROMETER EQUIPMENT JZT BIOMERIEUX INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *