BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK

    MDR report key: 20399423 · Received October 8, 2024

    Report

    Report Number
    3007111389-2024-00191
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 9, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEC
    UDI-DI
    10758750008971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER REPORTED THAT REPRODUCIBLE HIGHER THAN EXPECTED VITROS FT4 RESULTS AND REPRODUCIBLE LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO FT4 AND TSH RESULTS OBTAINED FROM THE SAME SAMPLE TESTED WITH A NON-VITROS ROCHE COBAS METHOD. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN. AN UNKNOWN SAMPLE SPECIFIC INTERFERENT THAT AFFECTS THE VITROS ASSAYS BUT NOT THE ROCHE COBAS ASSAYS CANNOT BE RULED OUT. THE RESULTS ARE REPRODUCIBLE ON TWO DIFFERENT VITROS INSTRUMENTS INDICATING THE RESULTS ARE THE EXPECTED RESULTS USING THE VITROS ASSAYS. DIAGNOSTIC WITHIN-LAB PRECISION TESTING WAS WITHIN ACCEPTABLE GUIDELINES, INDICATING AN INSTRUMENT RELATED ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. HISTORICAL QUALITY CONTROL RESULTS INDICATED BOTH VITROS FT4 REAGENT LOT 5560 AND VITROS TSH REAGENT LOT 7320 WERE PERFORMING AS INTENDED ON THE VITROS 5600 SYSTEM. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH EITHER VITROS FT4 REAGENT LOT 5560 OR VITROS TSH REAGENT LOT 7320.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE HIGHER THAN EXPECTED VITROS FT4 RESULTS AND REPRODUCIBLE LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO FT4 AND TSH RESULTS OBTAINED FROM THE SAME SAMPLE TESTED WITH A NON-VITROS ROCHE COBAS METHOD. PATIENT SAMPLE 2 VITROS FT4 RESULTS OF 3.73 AND 3.85 NG/DL VS. THE ROCHE COBAS FT4 RESULT OF 0.77 NG/DL. PATIENT SAMPLE 2 VITROS TSH RESULTS OF 1.73 AND 1.72 NG/DL VS. THE ROCHE COBAS TSH RESULT OF 17.3 NG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS FT4 AND TSH RESULTS OBTAINED FROM THE PATIENT SAMPLE WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER STATED THAT NO CORRECTED REPORTS WERE ISSUED, HOWEVER, NO TREATMENT WAS STOPPED, STARTED OR ALTERED BASED ON THE VITROS FT4 AND TSH RESULTS REPORTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO 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
    635750 VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK IN-VITRO DIAGNOSTICS CEC ORTHO-CLINICAL DIAGNOSTICS, INC. 5560 10758750008971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown