BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 16709433 · Received April 10, 2023

    Report

    Report Number
    3007111389-2023-00056
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 10, 2023
    Report Date
    April 7, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JLW
    UDI-DI
    10758750000227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULT AND A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS FT4 RESULT WAS OBTAINED FROM A SAMPLE FROM A SINGLE PATIENT WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE FOR THE DISCORDANT LOWER THAN EXPECTED VITROS TSH RESULT AND HIGHER THAN EXPECTED VITROS FT4 RESULT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. A VITROS TSH AND FT4 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS THE CUSTOMER MADE NO SUGGESTION OF ANY ISSUES WITH THE QC FLUIDS PROCESSED AT THE CUSTOMER SITE AND NO ISSUES REGARDING ACCURACY OR PRECISION OF THE VITROS ASSAYS WERE INDICATED BY THE CUSTOMER. FURTHERMORE, PRECISION TESTING OF THE VITROS 5600 INTEGRATED SYSTEMS WAS NOT PERFORMED, THEREFORE IT CANNOT BE CONFIRMED THAT THE INSTRUMENT WAS OPERATING AS INTENDED AND UNEXPECTED INSTRUMENT PERFORMANCE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT POSSIBLE TO ESTABLISH IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE¿S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE ALTHOUGH THIS COULD NOT BE CONFIRMED. FURTHERMORE, A SAMPLE SPECIFIC INTERFERENT CANNOT BE RULED OUT AS THE CAUSE OF THE DISCORDANT VITROS TSH AND VITROS FT4 RESULTS OBTAINED FOR PATIENT A. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH ANY OF THE VITROS PRODUCTS ASSOCIATED WITH THIS ISSUE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULT AND A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS FT4 RESULT WAS OBTAINED FROM A SAMPLE FROM A SINGLE PATIENT WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT A TSH RESULT OF 0.259 MIU/L VERSUS THE EXPECTED RESULT OF 2.21 MIU/L PATIENT A FT4 RESULT OF 2.52 NG/DL VERSUS THE EXPECTED RESULT OF 0.7 NG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY AND TREATMENT WAS BOTH ADMINISTERED AND DELAYED BASED ON THE REPORTED RESULTS. HOWEVER, ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S 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 601512 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020207 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 1912997 6990 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown