BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 23424119 · Received October 30, 2025

    Report

    Report Number
    3007111389-2025-00115
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 30, 2025
    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 LOWER THAN EXPECTED VITROS THYROID STIMULATING HORMONE (TSH) RESULTS WERE OBTAINED FROM A SINGLE LEVEL (L1) OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS CONTROL FLUID WHILE USING VITROS TSH REAGENT LOT 7511 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS TSH QUALITY CONTROL RESULTS COULD NOT BE DETERMINED. ACCEPTABLE VITROS TSH PERFORMANCE WAS OBTAINED USING BIORAD QC FLUID (L3), A SINGLE LEVEL (L2) OF VITROS TOTAL THYROID CONTROL (TTC) DURING A VITROS TSH DIAGNOSTIC PRECISION STUDY, AND VITROS TTC L2 AND L3 TWO WEEKS LATER. HOWEVER, VITROS TTC L1 WAS OBSERVED TO BE OUTSIDE THE VITROS PACKAGE INSERT (PI) RANGE ON THE LOW END AND THIS DATA POINT BREACHED PHS CRITERIA FOR THE VITROS TSH ASSAY. THE CUSTOMER AND ORTHO TSC BELIEVED THE LOWER THAN EXPECTED BIORAD QC RESULTS WERE ISOLATED TO THE BIORAD QC L1 FLUID IN USE AT THE CUSTOMER SITE. HOWEVER, AS VITROS TTC L1 FLUID WAS ALSO AFFECTED AND NO DEFINITIVE CAUSE OF THE LOWER THAN EXPECTED VITROS TTC L1 RESULT WAS DETERMINED, IT CANNOT BE CONCLUDED THAT THIS ISSUE IS ONLY ISOLATED TO THE NON-VITROS BIORAD QC FLUID. CALIBRATION PARAMETERS WERE REVIEWED FOR ALL CALIBRATION EVENTS AND WERE WITHIN ALLOWABLE LIMITS, INDICATING TYPICAL CALIBRATION EVENTS. THEREFORE, A CALIBRATION-RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR TO THIS EVENT. VITROS TSH WITHIN-RUN PRECISION TESTING WAS WITHIN EXPECTATION, INDICATING THAT AN ISSUE WITH THE XT 7600 INTEGRATED SYSTEM WAS NOT A LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, AS NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED, AN INSTRUMENT RELATED ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. THE TECHNICAL SUPPORT SPECIALIST CONFIRMED THAT THE CUSTOMER WAS FOLLOWING ORTHO MANUFACTURER RECOMMENDATIONS FOR QC SAMPLE HANDLING, THEREFORE A QC FLUID HANDLING ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS TSH REAGENT LOT 7511.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS THYROID STIMULATING HORMONE (TSH) RESULTS WERE OBTAINED FROM A SINGLE LEVEL (L1) OF NON-VITROS BIORAD LIQUICHEK IMMUNOASSAY PLUS CONTROL FLUID WHILE USING VITROS TSH REAGENT LOT 7511 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD L1 LOT 1003930 VITROS TSH RESULTS OF 0.416, 0.419, AND 0.423 MIU/L VERSUS THE EXPECTED RESULT OF 0.624 MIU/L. 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-THAN-EXPECTED VITROS TSH RESULTS WERE OBTAINED WHEN PROCESSING NON-PATIENT CONTROL FLUIDS. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT PATIENT RESULTS WERE NOT IMPACTED BY THIS ISSUE. THERE HAS BEEN NO REPORTED 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
    1342694 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7511 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown