BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK

    MDR report key: 17377814 · Received July 24, 2023

    Report

    Report Number
    3007111389-2023-00121
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 21, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEC
    UDI-DI
    10758750008971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED FREE T4 (FT4) RESULTS WERE OBTAINED FROM VITROS FREE THYROID CONTROL (FTC) FLUID WHEN USING VITROS IMMUNODIAGNOSTIC PRODUCTS FT4 REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED VITROS FT4 RESULTS COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE LOW FT4 QC RESULTS WERE ISOLATED TO THE FTC QC FLUIDS WITH AN UNKNOWN LOT NUMBER. NO FURTHER INVESTIGATION OF THOSE FTC QC FLUIDS WAS PERFORMED AND THEREFORE, AN ISSUE WITH THE LOT UNKNOWN FTC FLUIDS COULD NOT BE CONFIRMED OR RULED OUT AS A POTENTIAL CONTRIBUTOR TO THE EVENT. INSTRUMENT PERFORMANCE IS NOT A LIKELY CONTRIBUTOR TO THE EVENTS. HOWEVER, IT CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR AS PRECISION TESTING TO ASSESS INSTRUMENT PERFORMANCE WAS NOT PERFORMED BY THE CUSTOMER. PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT CLEARLY DETERMINED IF THE CUSTOMER WAS FOLLOWING THE CORRECT RECOMMENDATION FOR CONTROL STORAGE, PREPARATION AND SAMPLE HANDLING. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS FT4 REAGENT LOT 5260.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED FREE T4 (FT4) RESULTS WERE OBTAINED FROM VITROS FREE THYROID CONTROL (FTC) FLUID WHEN USING VITROS IMMUNODIAGNOSTIC PRODUCTS FT4 REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. FTC LEVEL 2 VITROS FT4 RESULT OF 1.86 NG/DL ON INST J1 VERSUS THE EXPECTED RESULT OF 2.46 NG/DL FTC LEVEL 2 VITROS FT4 RESULTS OF 1.79 NG/DL ON INST J2 VERSUS THE EXPECTED RESULT OF 2.46 NG/DL 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 RESULTS WERE OBTAINED FROM NON-PATIENT SAMPLE QC FLUIDS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4), (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748744 VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK IN-VITRO DIAGNOSTICS CEC ORTHO-CLINICAL DIAGNOSTICS, INC. 5260 10758750008971

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown