BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 24899655 · Received April 16, 2026

    Report

    Report Number
    3007111389-2026-00079
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 21, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JLW
    UDI-DI
    10758750000227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT DISCORDANT, LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED WHEN SAMPLES FROM TWO DIFFERENT PATIENTS WERE TESTED USING VITROS TSH LOT 7601 AND VITROS TSH LOT 7610 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO ROCHE TSH RESULTS FOR THE SAME PATIENT SAMPLES. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. THERE WAS NO REPORT OF ANY ISSUES WITH QC PERFORMANCE AT THE CUSTOMER SITE FROM VITROS TSH LOT 7601 AND LOT 7160 TESTING AND ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS TSH LOT 7601 OR LOT 7160. WITHIN RUN PRECISION TESTING PERFORMED WAS WITHIN ORTHO ACCEPTABLE GUIDELINES, SUGGESTING AN INSTRUMENT ISSUE WAS NOT LIKELY A CONTRIBUTING FACTOR. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS ESTABLISHED THAT THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURES RECOMMENDATION FOR SAMPLE CENTRIFUGATION AND CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS LIKELY PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. IT WAS NOT KNOWN WHETHER THE PATIENTS WERE IN RECEIPT OF A BIOTIN SUPPLEMENT. FOR THE VITROS TSH ASSAY, A NEGATIVE BIAS MAY BE OBSERVED (GREATER THAN 10% BIAS) IN SAMPLES WITH A BIOTIN CONCENTRATION OF 5 NG/ML (0.5 UG/DL). IN ADDITION, AN INTERFERENT THAT AFFECTS THE VITROS TSH METHOD AND NOT THE ROCHE TSH METHOD CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT AS NO TESTING TO RULE OUT A SAMPLE SPECIFIC INTERFERENT WAS CONDUCTED.

    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 TWO DIFFERENT PATIENTS WERE TESTED USING VITROS TSH LOT 7601 AND VITROS TSH LOT 7610 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO ROCHE TSH RESULTS FOR THE SAME PATIENT SAMPLES. PATIENT 1, VITROS TSH LOT 7601 RESULT OF <0.015 MIU/L (HYPERTHYROID) VERSUS A ROCHE TSH RESULT OF 1.39 MIU/L (EUTHYROID) PATIENT 2, VITROS TSH LOT 7610 RESULT OF 0.063 MIU/L (HYPERTHYROID) VERSUS A ROCHE TSH RESULT OF 1.88 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, LOWER THAN EXPECTED VITROS TSH RESULTS WERE REPORTED FROM THE LABORATORY, HOWEVER, CORRECTED REPORTS DOCUMENTING THE ROCHE TSH RESULTS WERE LATER ISSUED. NO TREATMENT WAS ALTERED, INITIATED OR STOPPED DUE TO THE INITIALLY REPORTED VITROS TSH RESULTS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT 614098.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957842 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7610 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown