BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1832457 · Received September 13, 2010

    Report

    Report Number
    1319681-2010-00193
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 14, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE FALSELY ELEVATED TROP I ES RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE CAUSE. THE POSSIBILITY THAT AN ANALYZER RELATED EVENT, OR POOR ANALYZER MAINTENANCE CONTRIBUTED TO THE BIASED RESULTS COULD NOT BE RULED OUT. ADDITIONALLY, THE INVESTIGATION COULD NOT DETERMINE WHETHER THE SAMPLES IN QUESTION WERE PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FROM TWO DIFFERENT PATIENT SAMPLES WHEN PROCESSED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE NON-REPEATABLE HIGHER THAN EXPECTED VITROS TROPI ES RESULT FOR ONE PATIENT (PATIENT WAS REPORTED FROM THE LABORATORY, AND A CORRECTED RESULT WAS ISSUED. IT WAS CONFIRMED THAT NO TREATMENT WAS INITIATED OR ALTERED BASED ON THE REPORTED RESULT, AND THERE WAS NO REPORT OF HARM TO THE PATIENT. IT IS UNKNOWN IF THE NON-REPEATABLE HIGHER THAN EXPECTED VITROS TROPI ES RESULT FOR THE SECOND PATIENT (PATIENT 2) WAS REPORTED FROM THE LABORATORY AS THIS INFORMATION WAS NOT PROVIDE. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1