BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 18722358 · Received February 16, 2024

    Report

    Report Number
    3007111389-2024-00028
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 15, 2024
    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 AND HIGHER THAN EXPECTED TSH RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT LOT 7190 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS METHOD. THE ASSIGNABLE CAUSE FOR THE LOWER AND HIGHER THAN EXPECTED PATIENT SAMPLE RESULTS COULD NOT BE DETERMINED. A REVIEW OF HISTORICAL QC FLUID RESULTS CONCLUDED THE VITROS TSH RESULTS WERE ACCURATE AND PRECISE. ADDITIONALLY, THE TSH QC RESULTS REVIEWED FROM THE TIMEFRAME OF 03 JANUARY 2024 THROUGH 24 JANUARY 2024 (DURING THE DATES OF THE EVENTS) WERE ACCURATE AND PRECISE. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS TSH, LOT 7190. THEREFORE, A VITROS TSH REAGENT LOT 7190 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. THE CUSTOMER DID NOT REPORT ANY INSTRUMENT ISSUES AND A REVIEW OF E-CONNECTIVITY DID NOT IDENTIFY ANY INSTRUMENT CONDITION CODES POSTED AROUND THE TIME OF THE EVENTS. THE CUSTOMER DID NOT CARRY OUT A PRECISION TEST ON THE VITROS 5600 INTEGRATED SYSTEM WHEN REQUESTED. THEREFORE, AN INSTRUMENT RELATED ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR OF THE EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT POSSIBLE TO DETERMINE WHETHER THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURES RECOMMENDATION FOR SAMPLE CENTRIFUGATION, CONSEQUENTLY, IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE. NO INFORMATION WAS PROVIDED ON HOW THE PATIENT SAMPLES WERE STORED AND HANDLED BETWEEN TESTING EVENTS AT CUSTOMER SITE AND REFERENCE LAB. THEREFORE, IT IS POSSIBLE HANDLING AND STORAGE OF THE PATIENT SAMPLES BETWEEN TESTING EVENTS CONTRIBUTED TO THE LOWER AND HIGHER THAN EXPECTED PATIENT SAMPLE RESULTS, ALTHOUGH THIS CANNOT BE CONFIRMED. IT IS POSSIBLE AN UNKNOWN INTERFERENT THAT AFFECTS THE VITROS TSH METHOD AND NOT THE QUEST METHOD CONTRIBUTED TO THE LOWER AND HIGHER THAN EXPECTED PATIENT SAMPLE RESULTS, HOWEVER, THIS WAS NOT CONFIRMED. PER THE TSH INSTRUCTION FOR USE: HETEROPHILIC ANTIBODIES IN SERUM OR PLASMA SAMPLES MAY CAUSE INTERFERENCE IN IMMUNOASSAYS, CERTAIN DRUGS AND CLINICAL CONDITIONS ARE KNOWN TO ALTER TSH CONCENTRATIONS IN VIVO, AND THYROID HORMONE AUTOANTIBODIES IN SAMPLES MAY CAUSE INTERFERENCE WITH THIS TEST.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED TSH RESULTS WERE OBTAINED FROM A NUMBER OF DIFFERENT PATIENT SAMPLES WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT LOT 7190 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS METHOD. PATIENT 1 VITROS TSH RESULT OF 0.02 MIU/L VS. THE EXPECTED RESULT OF 0.33 MIU/L (QUEST). PATIENT 2 VITROS TSH RESULT OF 0.02 MIU/L VS. THE EXPECTED RESULT OF 2.41 MIU/L (QUEST). PATIENT 3 VITROS TSH RESULT OF 0.34 MIU/L VS. THE EXPECTED RESULT OF 2.07 MIU/L (QUEST). PATIENT 4 VITROS TSH RESULT OF 0.39 MIU/L VS. THE EXPECTED RESULT OF 0.56 MIU/L (QUEST). PATIENT 5 VITROS TSH RESULT OF 0.20 MIU/L VS. THE EXPECTED RESULT OF 1.14 MIU/L (QUEST). PATIENT 6 VITROS TSH RESULT OF 0.30 MIU/L VS. THE EXPECTED RESULT OF 1.15 MIU/L (QUEST). PATIENT 7 VITROS TSH RESULT OF 0.12 MIU/L VS. THE EXPECTED RESULT OF 2.05 MIU/L (QUEST). PATIENT 8 VITROS TSH RESULT OF 0.33 MIU/L VS. THE EXPECTED RESULT OF 1.12 MIU/L (QUEST). PATIENT 9 VITROS TSH RESULT OF 0.37 MIU/L VS. THE EXPECTED RESULT OF 2.02 MIU/L (QUEST). PATIENT 11 VITROS TSH RESULT OF 0.39 MIU/L VS. THE EXPECTED RESULT OF 2.25 MIU/L (QUEST). PATIENT 12 VITROS TSH RESULT OF 0.28 MIU/L VS. THE EXPECTED RESULT OF 0.42 MIU/L (QUEST). PATIENT 13 VITROS TSH RESULT OF 0.34 MIU/L VS. THE EXPECTED RESULT OF 2.88 MIU/L (QUEST). PATIENT 14 VITROS TSH RESULT OF 0.12 MIU/L VS. THE EXPECTED RESULT OF 0.23 MIU/L (QUEST). PATIENT 16 VITROS TSH RESULT OF 2.99 MIU/L VS. THE EXPECTED RESULT OF 2.09 MIU/L (QUEST). PATIENT 17 VITROS TSH RESULT OF 0.16 MIU/L VS. THE EXPECTED RESULT OF 1.44 MIU/L (QUEST). PATIENT 18 VITROS TSH RESULT OF 0.38 MIU/L VS. THE EXPECTED RESULT OF 0.56 MIU/L (QUEST). PATIENT 19 VITROS TSH RESULT OF 0.15 MIU/L VS. THE EXPECTED RESULT OF 0.50 MIU/L (QUEST). PATIENT 20 VITROS TSH RESULT OF 0.30 MIU/L VS. THE EXPECTED RESULT OF 3.47 MIU/L (QUEST). PATIENT 21 VITROS TSH RESULT OF 0.18 MIU/L VS. THE EXPECTED RESULT OF 1.58 MIU/L (QUEST). PATIENT 22 VITROS TSH RESULT OF 0.32 MIU/L VS. THE EXPECTED RESULT OF 1.28 MIU/L (QUEST). PATIENT 24 VITROS TSH RESULT OF 0.28 MIU/L VS. THE EXPECTED RESULT OF 2.53 MIU/L (QUEST). PATIENT 25 VITROS TSH RESULT OF 0.16 MIU/L VS. THE EXPECTED RESULT OF 2.33 MIU/L (QUEST). PATIENT 26 VITROS TSH RESULT OF 0.28 MIU/L VS. THE EXPECTED RESULT OF 0.42 MIU/L (QUEST). PATIENT 28 VITROS TSH RESULT OF 0.17 MIU/L VS. THE EXPECTED RESULT OF 0.27 MIU/L (QUEST). PATIENT 29 VITROS TSH RESULT OF 0.33 MIU/L VS. THE EXPECTED RESULT OF 1.33 MIU/L (QUEST). PATIENT 30 VITROS TSH RESULT OF 0.03 MIU/L VS. THE EXPECTED RESULT OF 2.56 MIU/L (QUEST). PATIENT 31 VITROS TSH RESULT OF 0.16 MIU/L VS. THE EXPECTED RESULT OF 0.93 MIU/L (QUEST). PATIENT 32 VITROS TSH RESULT OF 0.33 MIU/L VS. THE EXPECTED RESULT OF 0.60 MIU/L (QUEST). PATIENT 33 VITROS TSH RESULT OF 0.19 MIU/L VS. THE EXPECTED RESULT OF 2.36 MIU/L (QUEST). PATIENT 34 VITROS TSH RESULT OF 0.18 MIU/L VS. THE EXPECTED RESULT OF 1.42 MIU/L (QUEST). PATIENT 35 VITROS TSH RESULT OF 0.20 MIU/L VS. THE EXPECTED RESULT OF 0.14 MIU/L (QUEST). PATIENT 37 VITROS TSH RESULT OF 0.30 MIU/L VS. THE EXPECTED RESULT OF 1.50 MIU/L (QUEST). PATIENT 38 VITROS TSH RESULT OF 0.32 MIU/L VS. THE EXPECTED RESULT OF 1.28 MIU/L (QUEST). PATIENT 39 VITROS TSH RESULT OF 0.16 MIU/L VS. THE EXPECTED RESULT OF 1.44 MIU/L (QUEST). PATIENT 40 VITROS TSH RESULT OF 0.28 MIU/L VS. THE EXPECTED RESULT OF 2.53 MIU/L (QUEST). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER AND HIGHER THAN EXPECTED VITROS TSH RESULTS WAS NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO 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) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378421 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7190 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown