BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 20150654 · Received September 5, 2024

    Report

    Report Number
    3007111389-2024-00172
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    July 29, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JLW
    UDI-DI
    10758750000227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN SAMPLES FROM TWELVE DIFFERENT PATIENTS WERE TESTED USING VITROS TSH LOT 7360 ON A VITROS XT 7600 INTEGRATED SYSTEM AND A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAME PATIENT SAMPLES. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. ACCEPTABLE ACCURACY WAS OBSERVED FROM VITROS TSH LOT 7360 RESULTS FROM IN-HOUSE CONTROL TESTING, HOWEVER, UNACCEPTABLE WITHIN LABORATORY PRECISION WAS OBSERVED FOR TWO OUT OF SIX OF THE IN-HOUSE CONTROLS. THEREFORE, A VITROS TSH LOT 7360 REAGENT ISSUE CANNOT BE COMPLETED RULED OUT AS A CONTRIBUTOR TO THE EVENT. HOWEVER, ONGOING TRACKING AND TRENDING DID NOT IDENTIFY ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS TSH LOT 7360. NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED ON THE INSTRUMENTS, THEREFORE, INSTRUMENT RELATED ISSUES CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTOR TO THE EVENT. HOWEVER, INSTRUMENT ISSUES ARE UNLIKELY CONTRIBUTORS TO THE EVENT AS VITROS TSH3 RESULTS ON THE INSTRUMENTS WERE REPRODUCIBLE ACROSS THREE DIFFERENT KIT LOTS ON THE INSTRUMENTS AND IN-HOUSE CONTROL TESTING PRODUCED ACCEPTABLE VITROS TSH RESULTS. SAMPLE INTERFERENCE IN THE VITROS TSH ASSAY CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS NO TESTING TO RULE OUT A SAMPLE SPECIFIC INTERFERENT IN THE SAMPLES WAS CONDUCTED. ADDITIONALLY, IT WAS NOT POSSIBLE TO ESTABLISH IF THE DONORS INVOLVED IN THE STUDY WERE IN RECEIPT OF A BIOTIN SUPPLEMENT. FURTHERMORE, THE EXPECTED RESULTS FOR THE SAMPLES WERE OBTAINED FROM THE VITROS TSH3 METHOD, WHICH IS NOT AFFECTED BY BIOTIN INTERFERENCE. THEREFORE, BIOTIN INTERFERENCE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE DISCORDANT, LOWER THAN EXPECTED VITROS TSH RESULTS.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN SAMPLES FROM TWELVE DIFFERENT PATIENTS WERE TESTED USING VITROS TSH LOT 7360 ON A VITROS XT 7600 INTEGRATED SYSTEM AND A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO VITROS TSH3 RESULTS FOR THE SAME PATIENT SAMPLES. SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.448 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 2.597 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.089 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 1.383 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.306 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 0.46 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.41 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 1.846 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.25 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 2.059 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.01 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 0.764 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.39 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 1.534 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.02 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 1.142 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.264 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 3.39 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.004 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 1.485 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.15 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 1.961 MIU/L (EUTHYROID) SAMPLE ID (B)(6), VITROS TSH RESULT OF 0.343 MIU/L (HYPOTHYROID) VERSUS THE EXPECTED RESULT OF 0.626 MIU/L (EUTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT VITROS RESULTS WERE TESTED AS PART OF AN INTERNAL CORRELATION STUDY AT ORTHO PENCOED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) NONCONFORMANCE (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140108 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7360 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown