BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1181746 · Received September 18, 2008

    Report

    Report Number
    1319681-2008-00284
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 16, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT HAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE WAS USER ERROR. INVESTIGATION OF DATALOGGERS COLLECTED AT THE TIME OF THE EVENT INDICATE THAT THE SAMPLE VISCOSITY AND VOLUME IN THE SAMPLE WAS DIFFERENT THAN THAT OF THE REPEAT SAMPLE ANALYSIS. THE INVESTIGATION CONCLUDED THAT THE INCORRECT PT RESULTS MOST LIKELY WERE ASSOCIATED WITH AN INCORRECT SAMPLE OR SAMPLE TUBE TYPE THAT WAS PLACED ON THE INSTRUMENT BY THE USER. THERE WAS NO INDICATION OF INSTRUMENT MALFUNCTIONS OR INSTRUMENT ERRORS DURING THE TIME THE ORIGINAL SAMPLE WAS ASSAYED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED DISCORDANT VITROS GLU, K+, AND CA PATIENT RESULTS ON A VITROS 5,1 FS ANALYZER. THE RESULTS WERE REPORTED AND ACTED UPON BY THE PATIENT'S PHYSICIAN. THE PT WAS ADMITTED TO A HOSPITAL AND TREATMENT INITIATED BASED ON INCORRECT RESULTS. THE CUSTOMER BECAME AWARE OF THE DISCORDANT RESULT WHEN A SECOND SAMPLE WAS ASSAYED AND THE RESULTS DID NOT AGREE WITH INITIAL TESTING. A REPEAT ANALYSIS OF THE ORIGINAL SAMPLE CONFIRMED THAT THE ORIGINAL RESULTS WERE INCORRECT AND A CORRECTED REPORT WAS GENERATED. THE CUSTOMER STATES THERE WAS NO ALLEGATION OF PT HARM AS A RESULT OF THIS EVENT ALTHOUGH TREATMENT WAS INITIATED. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1