BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 15746415 · Received November 7, 2022

    Report

    Report Number
    1319681-2022-00046
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 7, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM VITROS FTC AND TTC QUALITY CONTROL FLUIDS, WHEN COMPARED TO THE VITROS PACKAGE INSERT MEANS WHEN TESTED USING VITROS TSH LOT 6800 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THE ORTHO TSC ESTABLISHED THAT THE CUSTOMER HAD ALTERED THE SLOPE AND INTERCEPT SETTINGS ON THEIR VITROS 3600 SYSTEM RESULTING IN THE MODIFIED, INCORRECT RESULTS FOR THE QC SAMPLES TESTED. THE CUSTOMER RESET THE SLOPE AND INTERCEPT PARAMETERS ON THE VITROS 3600 SYSTEM AND OBTAINED ACCEPTABLE CALIBRATION AND VITROS FTC QC FLUID RESPONSES FOLLOWING THE RESET. (B)(4)

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM VITROS FTC AND TTC QUALITY CONTROL FLUIDS, WHEN COMPARED TO THE VITROS PACKAGE INSERT MEANS WHEN TESTED USING VITROS TSH LOT 6800 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS FTC LOT 0700 LEVEL1 RESULT OF 4.017 MIU /ML VERSUS EXPECTED RESULT OF 0.042 MIU/ML VITROS FTC LOT 0700 LEVEL 2 RESULT OF 4.930 MIU /ML VERSUS EXPECTED RESULT OF 2.34 MIU/ML VITROS FTC LOT 0700 LEVEL 3 RESULT OF 10.96 MIU /ML VERSUS EXPECTED RESULT OF 17.4 MIU/ML VITROS TTC LOT 0810 LEVEL 1 RESULT OF 5.009 MIU /ML VERSUS EXPECTED RESULT OF 0.62 MIU/ML VITROS TTC LOT 0810 LEVEL 2 RESULT OF 4.021 MIU /ML VERSUS EXPECTED RESULT OF 2.41 MIU/ML VITROS TTC LOT 0810 LEVEL 3 RESULT OF 13.41 MIU /ML VERSUS EXPECTED RESULT OF 23.2 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER AND HIGHER THAN EXPECTED VITROS TSH RESULTS WERE FROM NON-PATIENT QC FLUIDS. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED, THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854080 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown