BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 23491131 · Received November 6, 2025

    Report

    Report Number
    3007111389-2025-00123
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JLW
    UDI-DI
    10758750000227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING A VITROS IMMUNODIAGNOSTICS PRODUCT TSH REAGENT LOT 7480 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO TWO DIFFERENT NON-VITROS METHODS (BECKMAN AND ROCHE). A DEFINITIVE CAUSE FOR THE LOWER THAN EXPECTED PATIENT SAMPLE RESULTS COULD NOT BE DETERMINED. A VITROS TSH LOT 7480 REAGENT RELATED ISSUE IS NOT A LIKELY A CONTRIBUTOR TO THE EVENT AS HISTORICAL QC FLUID RESULTS WERE ACCURATE AND PRECISE. ADDITIONALLY, ONGOING TRACKING AND TRENDING DOES NOT INDICATE ANY PERFORMANCE CONCERNS WITH THIS LOT. PRECISION TESTING WAS NOT PERFORMED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THEREFORE, AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THIS EVENT. HOWEVER, HISTORICAL VITROS QC FLUID RESULTS WERE WITHIN EXPECTATIONS, AND NO EVIDENCE OF INSTRUMENT MALFUNCTION WAS REPORTED. THEREFORE, AN INSTRUMENT ISSUE IS AN UNLIKELY CAUSE OF THE EVENT. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT AS IT WAS ESTABLISHED THAT THE CUSTOMER WAS NOT FOLLOWING THE MANUFACTURE'S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. CONSEQUENTLY, IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. NO TESTING WAS PERFORMED TO RULE OUT THE PRESENCE OF A SAMPLE INTERFERENT IN THE PATIENT'S SAMPLE, AND NO INFORMATION ON BIOTIN SUPPLEMENT INTAKE WAS PROVIDED. THEREFORE, AN INTERFERENT SPECIFIC TO THE VITROS TSH METHOD OR POTENTIAL BIOTIN INTERFERENCE CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR. THE PATIENT WAS A 28 YEAR OLD FEMALE WITH HYPOTHYROIDISM, CURRENTLY TAKING AN ALTERNATING DOSE OF 100/75 UG OF THYROXINE. CONSEQUENTLY, THE CHU REQUESTED A MEDICAL CONSULTATION FROM AN ORTHO MEDICAL SAFETY ADVISOR (MSA), WHO REPORTED THE FOLLOWING: "A 28 YEAR OLD FEMALE WITH KNOWN HYPOTHYROIDISM, CURRENTLY ON ALTERNATING DOSES OF THYROXINE, HAD A LOWER THAN EXPECTED VITROS TSH RESULT WITHIN THE EUTHYROID VITROS TSH RANGE. REPEAT TESTING WITH A NON-VITROS METHOD RETURNED A TSH LEVEL WITHIN THE HYPOTHYROID RANGE FOR THE PATIENT. PATIENTS ON REPLACEMENT THERAPY FOR HYPOTHYROIDISM UNDERGO ROUTINE MONITORING OF THEIR THYROID HORMONES, NOTABLY THE TSH AND THE FREE T4 (FT4). THE TIMING OF A PATIENT'S MONITORING DEPENDS ON WHETHER AN EUTHYROID RANGE HAS BEEN ESTABLISHED AND THE PATIENT IS ONLY ON MAINTENANCE DOSES, OR IF THE PATIENT'S REPLACEMENT DOSES ARE STILL BEING TITRATED TO ACHIEVE A STEADY STATE. IN ADDITION TO BIOCHEMICAL MONITORING, PATIENTS ARE ALSO MONITORED FOR CESSATION OF SYMPTOMS AND IMPROVEMENT IN THEIR OVERALL HEALTH, SUCH AS IMPROVEMENT IN HEART RATE, COLD INTOLERANCE, WEIGHT LOSS, ETC. A FALSELY REDUCED RESULT DURING EITHER THE MAINTENANCE PHASE OR INITIATION PHASE MAY RESULT IN AN INAPPROPRIATE REDUCTION IN THE PATIENT'S THYROXINE REPLACEMENT DOSAGE. IN SUCH INSTANCES, A REDUCTION IN THE PATIENT'S DOSE MAY PREDISPOSE THE PATIENT TO THE RETURN OF SYMPTOMS; HOWEVER, IMMEDIATE SERIOUS PATIENT INJURY IS UNLIKELY. FOLLOWING DOSE ADJUSTMENT, BIOCHEMICAL MONITORING IS OFTEN REPEATED IN ABOUT 4 TO 6 WEEKS. REPEAT TESTING INCREASES THE CHANCES OF DETECTING AN ERRONEOUS RESULT. LIKEWISE, DEPENDING ON THE COURSE OF PATIENT MANAGEMENT, AN INCORRECT RESULT MAY BE DISCORDANT WITH THE PATIENT'S PROGRESS. BASED ON THE INFORMATION PROVIDED, THE RESULT WAS NOT REPORTED FROM THE LABORATORY, AND THERE WAS NO INAPPROPRIATE PHYSICIAN INTERVENTION. OVERALL, THERE IS NO RISK TO THIS PATIENT, AND SERIOUS PATIENT INJURY IS NOT ANTICIPATED."

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING A VITROS IMMUNODIAGNOSTICS PRODUCT TSH REAGENT LOT 7480 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO TWO DIFFERENT NON-VITROS METHODS (BECKMAN AND ROCHE). PATIENT 1, SAMPLE 1 RESULTS OF 2.58 AND 2.59 MIU/L (EUTHYROID) VS THE EXPECTED RESULTS OF 13.64 AND 14.29 MIU/L (HYPOTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS TSH RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702589 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7480 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown