BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS

    MDR report key: 335469 · Received May 24, 2001

    Report

    Report Number
    1950204-2001-00007
    Event Type
    Malfunction
    Date Received
    May 24, 2001
    Date of Event
    May 11, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SCHEDULED PREVENTATIVE MAINTENANCE CHECK AT THE ACCOUNT THE FIELD SERVICE ENGINEER PERFORMED A STANDARD DIAGNOSTIC CHECK (QCT CHECK) AND THE INSTRUMENT FAILED THE TEST. THE PUMP WAS REPLACED AND IT WAS DETERMINED THAT THE PUMP HAD A CLOGGED PUMP TUBE IN POSITION C1. TEST RESULTS FOR THE PERIOD OF 3/2/2001-05/10/2001 ARE BEING EVALUATED TO DETERMINE IF PT RESULTS ARE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24671 VIDAS IMMUNOFLUROMETER EQUIPMENT JZT BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *