BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS TOBRA REAGENT

    MDR report key: 1022317 · Received March 28, 2008

    Report

    Report Number
    1319808-2008-00085
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE VITROS 5, 1 FS WAS OPERATING AS INTENDED. THE BIASED VITROS TOBRA RESULTS WERE OBTAINED DURING A METHOD COMPARISON WITH A COMPETITIVE SYSTEM. THE DEFINITIVE ROOT CAUSE IS UNK, BUT IS MOST LIKELY A COMBINATION OF INAPPROPRIATE SAMPLE STORAGE (FROZEN) PRIOR TO THE CORRELATION STUDY, INADEQUATE MIXING OF THE SAMPLES PRIOR TO PROCESSING, AND THE DIFFERENCES IN THE TOBRA CALIBRATIONS IN USE AT THE TIME OF THE STUDY.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED BIASED VITROS TOBRA RESULTS ON PT AND PROFICIENCY SAMPLES DURING A METHOD COMPARISON BETWEEN TWO VITROS 5, 1 FS CHEMISTRY SYSTEMS AND A COMPETITIVE SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE BIASED RESULTS WERE NOT REPORTED AND THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. THE REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS TOBRA REAGENT IN-VITRO DIAGNOSTIC LDO ORTHO-CLINICAL DIAGNOSTICS, INC. NA 1513-01-7371

    Patients

    Seq Age Sex Outcome Treatment
    1