BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 19939518 · Received August 8, 2024

    Report

    Report Number
    3007111389-2024-00151
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 7, 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 A LOWER THAN EXPECTED VITROS TSH RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT, LOT 7270 IN COMBINATION WITH A VITROS 500 INTEGRATED SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO A NON-VITROS ROCHE METHOD. THE ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED VITROS TSH RESULT WAS DUE TO A BIOTIN INTERFERENCE. ALTHOUGH NO PRECISION TESTING WAS PERFORMED ON THE VITROS 5600 SYSTEM AT THE TIME OF THE EVENT, HISTORICAL QC RESULTS WERE WITHIN EXPECTATION AND THERE WAS NO INDICATION THAT THE VITROS 5600 SYSTEM MALFUNCTIONED. THEREFORE, AN INSTRUMENT ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. THE CUSTOMER INFORMED THE ORTHO TSC THAT THE PATIENT WAS IN RECEIPT OF SUPPLEMENTS THAT CONTAIN A HIGH CONCENTRATION OF BIOTIN, ALTHOUGH THE EXACT BIOTIN CONCENTRATION WAS NOT PROVIDED. AS PER THE VITROS TSH INSTRUCTIONS FOR USE (IFU), KNOWN INTERFERENCE SECTION STATES THE FOLLOWING: "SPECIMENS WITH BIOTIN CONCENTRATIONS UP TO 2 NG/ML DEMONSTRATED A LESS THAN OR EQUAL TO 10% CHANGE IN RESULTS. BIOTIN CONCENTRATIONS GREATER THAN THIS FALSELY DECREASE TSH RESULTS FOR PATIENT SAMPLES." THEREFORE, IT IS CONFIRMED THAT BIOTIN INTERFERENCE WAS PRESENT IN THE PATIENT'S SAMPLE TAKEN ON 10 JULY 2024 WHICH LIKELY CONTRIBUTED TO THE LOWER THAN EXPECTED PATIENT SAMPLE RESULT OF 0.137 MIU/L. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS TSH REAGENT LOT 7270.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED VITROS TSH RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT, LOT 7270 IN COMBINATION WITH A VITROS 500 INTEGRATED SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO A NON-VITROS ROCHE METHOD. PATIENT 1 VITROS TSH RESULTS OF 0.137? IU/ML (HYPERTHYROID) VS EXPECTED ROCHE TSH RESULT OF 5.540? IU/ML (HYPOTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS TSH RESULT WAS REPORTED FROM THE LABORATORY. IT IS UNKNOWN IF TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULT. 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)(4) REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328146 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7270 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown