BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS SALI CHEMISTRY SLIDES

    MDR report key: 857656 · Received May 31, 2007

    Report

    Report Number
    1319809-2007-00151
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    May 3, 2007
    Report Date
    May 3, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THE RESULTS DID NOT CORRELATE WITH ANOTHER OEM METHOD. REPEAT TESTING RESULTS USING AN ALTERNATE SLIDE CART MATCHED THE ORIGINAL RESULTS. QC RESULTS WERE ACCEPTABLE. CALIBRATOR RESPONSES AND CALIBRATION PARAMETERS WERE ACCEPTABLE. AFTER OBTAINING FRESH SAMPLES, ACCEPTABLE CORRELATION WAS OBTAINED BETWEEN VITROS AND THE OEM METHOD. THE BIASED RESULTS ARE CONFINED TO THE ORIGINAL SAMPLES, AND THE CUSTOMER IS INVESTIGATING THE TRANSFER CONTAINERS FROM THE ORIGINAL SAMPLES. THE ROOT CAUSE OF THE BIASED RESULTS HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED REPEATABLE NEGATIVELY BIASED SALI RESULTS DURING A CORRELATION STUDY ON THE 5, 1 FS ANALYZER. NO BIASED RESULTS WERE REPORTED. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS SALI CHEMISTRY SLIDES IN VITRO DIAGNOSTIC DKJ ORTHO-CLINICAL DIAGNOSTICS NA 2226-0049-8138

    Patients

    Seq Age Sex Outcome Treatment
    1 YR