BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 21733707 · Received March 31, 2025

    Report

    Report Number
    3007111389-2025-00029
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 31, 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 CONCLUDED THAT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN USING VITROS TSH REAGENT LOT 7410 ON TWO DIFFERENT VITROS XT7600 SYSTEMS. THE PATIENT RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE RESULTS OBTAINED FROM NON-VITROS ROCHE AND QUEST METHODS. THE ASSIGNABLE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS NO INDICATION VITROS TSH REAGENT LOT 7410 OR THE VITROS XT7600 INTEGRATED SYSTEMS MALFUNCTIONED. HISTORICAL TSH QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES AND ALTHOUGH THE CUSTOMER DID NOT COMPLETE DIAGNOSTIC PRECISION TESTING ON THE SYSTEMS, WITHIN-RUN PRECISION TESTING INDICATED THE VITROS XT7600 INTEGRATED SYSTEMS WERE PERFORMING AS INTENDED. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS TSH REAGENT LOT 7410. IT IS UNKNOWN IF THE CUSTOMER IS PROCESSING PATIENT SAMPLES PER THE TUBE MANUFACTURERS SPECIFICATIONS. THEREFORE, IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT, AND IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN USING VITROS TSH REAGENT LOT 7410 ON TWO DIFFERENT VITROS XT7600 SYSTEMS. THE PATIENT RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE RESULTS OBTAINED FROM NON-VITROS ROCHE AND QUEST METHODS. J1- 76001683 PATIENT 1 VITROS TSH RESULT OF 0.12 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 1.1 MIU/L (EUTHYROID). PATIENT 8 VITROS TSH RESULT OF 0.117 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 1.4 MIU/L (EUTHYROID). PATIENT 9 VITROS TSH RESULT OF 0.169 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.3 MIU/L (EUTHYROID). PATIENT 11 VITROS TSH RESULT OF 0.066 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.8 MIU/L (EUTHYROID). PATIENT 13 VITROS TSH RESULT OF 0.188 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.3 MIU/L (EUTHYROID). PATIENT 14 VITROS TSH RESULT OF 0.203 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.4 MIU/L (EUTHYROID). PATIENT 15 VITROS TSH RESULT OF 0.316 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.5 MIU/L (EUTHYROID). PATIENT 31 VITROS TSH RESULT OF 0.023 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.81 MIU/L (EUTHYROID). PATIENT 36 VITROS TSH RESULT OF <0.015 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 2.48 MIU/L (EUTHYROID). PATIENT 38 VITROS TSH RESULT OF <0.015 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 1.63 MIU/L (EUTHYROID). J2- 76001684 PATIENT 1 VITROS TSH RESULT OF 0.19 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 1.1 MIU/L (EUTHYROID). PATIENT 4 VITROS TSH RESULT OF 0.257 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.4 MIU/L (EUTHYROID). PATIENT 10 VITROS TSH RESULT OF 0.148 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.3 MIU/L (EUTHYROID). PATIENT 12 VITROS TSH RESULT OF 0.112 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.3 MIU/L (EUTHYROID). PATIENT 30 VITROS TSH RESULT OF 0.419 MIU/L (HYPERTHYROID) VS. THE NON-VITROS TSH RESULT OF 0.90 MIU/L (EUTHYROID). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. SOME OR ALL OF THE LOWER-THAN-EXPECTED VITROS TSH RESULTS OBTAINED FROM EACH PATIENT SAMPLE WERE REPORTED TO THE CLINICIAN. IT WAS INDICATED THAT ONE OF THE PATIENTS HAD A MEDICATION CHANGED BASED ON THE LOWER-THAN-EXPECTED VITROS TSH RESULT, HOWEVER THE PATIENT THAT WAS AFFECTED AND THE MEDICATION THAT WAS CHANGED WAS NOT SPECIFIED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF SEVEN MDRS FOR THIS EVENT. SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVEN DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166973 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7410 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown