BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY SYSTEM

    MDR report key: 1052444 · Received May 21, 2008

    Report

    Report Number
    1319681-2008-00146
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED OCD TO TROUBLESHOOT THE OCCURRENCE OF U90-382 CONDITION CODES ON QC FLUIDS AND INTERMITTENT PT SAMPLES. THE INVESTIGATION DETERMINED THAT THE VITROS 5, 1 AND VITROS PHYT SLIDES WERE OPERATING AS EXPECTED. THE ROOT CAUSE OF THE NON-REPRODUCIBLE PT RESULTS WAS UNABLE TO BE DETERMINED, HOWEVER, SAMPLE MIX UP OR SAMPLE HANDLING ISSUES COULD NOT BE RULED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NON-REPRODUCIBLE PT RESULTS FOR TWO PTS IN 2008, AND THE NEXT DAY USING VITROS PHYT SLIDES ON A VITROS 5, 1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED ON A PT SPECIMEN MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. CORRECTED REPORTS WERE ISSUED FOR THE TWO PTS. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5, 1 FS CHEMISTRY SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1