BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 18220787 · Received November 28, 2023

    Report

    Report Number
    3007111389-2023-00202
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JLW
    UDI-DI
    10758750000227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER REPORTED A HIGHER THAN EXPECTED VITROS TSH RESULT WAS OBTAINED FROM ONE OF FOUR INSTITUTE FOR QUALITY MANAGEMENT IN HEALTHCARE (IQMH) PROFICIENCY SAMPLES TESTED FROM THE MOST RECENT PROFICIENCY EVENT USING VITROS TSH REAGENT LOT 7020 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE FOR THE HIGHER THAN EXPECTED VITROS TSH RESULTS COULD NOT BE DETERMINED. NO PATIENT SAMPLE CORRELATION OR VITROS THYROID CONTROLS WERE PROCESSED BY THE CUSTOMER TO VERIFY THE ACCURACY OF THE VITROS TSH LOT 7020 REAGENT. HOWEVER, HISTORICAL QUALITY CONTROL RESULTS OBTAINED FROM BOTH VITROS TSH REAGENT LOTS WERE ACCEPTABLE DURING THE TIMEFRAME OF THE EVENT, THEREFORE, A VITROS TSH REAGENT PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. THERE WAS NO INDICATION THE VITROS 5600 SYSTEM MALFUNCTIONED, HOWEVER, SINCE NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED, A VITROS INSTRUMENT PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS TSH LOT 7020.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS TSH RESULT WAS OBTAINED FROM ONE OF FOUR INSTITUTE FOR QUALITY MANAGEMENT IN HEALTHCARE (IQMH) PROFICIENCY SAMPLES TESTED FROM THE MOST RECENT PROFICIENCY EVENT USING VITROS TSH REAGENT LOT 7020 ON A VITROS 5600 INTEGRATED SYSTEM. IQMH SAMPLE ENDO A2 RESULT OF 0.18 MIU/L VS. THE EXPECTED RESULT OF 0.07 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 HIGHER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A NON-PATIENT PROFICIENCY FLUID. THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLE RESULTS HAD BEEN AFFECTED OR QUESTIONED BY PHYSICIANS AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(6) AND (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532187 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7020 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown