BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK

    MDR report key: 17772483 · Received September 19, 2023

    Report

    Report Number
    3007111389-2023-00163
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 24, 2023
    Report Date
    September 18, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEC
    UDI-DI
    10758750008971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED FT4 RESULTS WERE OBTAINED WHEN A L1 VITROS FTC (LOT 0761) WAS PROCESSED USING VITROS FT4 LOT 5300 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS LIMITED HISTORICAL QC DATA AVAILABLE TO ASSESS VITROS FT4 REAGENT ASSAY PERFORMANCE AS THE INSTRUMENT HAD BEEN RECENTLY INSTALLED AT THE CUSTOMER SITE. HOWEVER, VITROS FT4 LOT 5300 RESULTS FROM TWO LEVELS OF VITROS FTCS WERE BIASED HIGH, THEREFORE A VITROS FT4 LOT 5300 REAGENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. THE CUSTOMER RECEIVED AN ALTERNATE LOT OF VITROS FT4 REAGENT (LOT 5333) AND VITROS FTC RESULTS WERE ACCEPTABLE FROM THIS LOT. AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS NO DIAGNOSTIC PRECISION TESTING WAS CONDUCTED AROUND THE TIME OF THE EVENT TO VERIFY THE PERFORMANCE OF THE INSTRUMENT. IMPROPER PRE-ANALYTICAL HANDLING IS AN UNLIKELY CONTRIBUTOR TO THE HIGHER THAN EXPECTED VITROS FT4 RESULTS, AS IT WAS CONFIRMED THAT THE CUSTOMER FOLLOWS THE CORRECT PROTOCOL FOR VITROS FTC PRE-ANALYTICAL FLUID HANDLING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT HIGHER THAN EXPECTED FT4 RESULTS WERE OBTAINED WHEN A LEVEL 1 CONTROL FROM VITROS FREE THYROID CONTROL (FTC) LOT 0761 WAS PROCESSED USING VITROS FT4 REAGENT LOT 5300 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS FTC LEVEL 1 = 1.07, 1.19, 1.13, 1.10, 1.11, 1.08 NG/DL VERSUS THE PI MEAN 0.75 NG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE RESULTS WERE TO RECUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS FT4 RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4)/REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880018 VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK IN VITRO DIAGNOSTICS CEC ORTHO-CLINICAL DIAGNOSTICS 1387000 5300 10758750008971

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown