BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 19060160 · Received April 8, 2024

    Report

    Report Number
    3007111389-2024-00073
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 3, 2024
    Report Date
    April 8, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER
    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

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A NON-VITROS RANDOX QUALITY CONTROL (QC) FLUID WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT LOT 7190 IN COMBINATION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. QUALITY CONTROL DATA INDICATES SOME WITHIN-LAB VITROS TSH IMPRECISION FOR THE RANDOX CONTROL, HOWEVER, THE IMPRECISION WAS SLIGHT WHEN COMPARED TO THE MAGNITUDE OF BIAS ASSOCIATED WITH THE HIGHER THAN EXPECTED VITROS TSH QC RESULTS. THEREFORE, A VITROS TSH REAGENT ISSUE IS AN UNLIKELY CONTRIBUTOR TO THIS EVENT BUT CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A QUALITY PERFORMANCE ISSUE WITH VITROS TSH REAGENT LOTS 7190. PRECISION TESTING CARRIED OUT ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM INDICATED ACCEPTABLE INSTRUMENT PERFORMANCE, HOWEVER, AS NO PRECISION TESTING WAS CARRIED OUT AT THE TIME OF THE EVENTS, AN INSTRUMENT ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR. THE CUSTOMER DID NOT PROVIDE THE RANDOX HANDLING AND STORAGE RECOMMENDATIONS, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF THE CUSTOMER WAS FOLLOWING THE RANDOX HANDLING OR STORAGE RECOMMENDATIONS. SUBSEQUENTLY, IT IS POSSIBLE THAT IMPROPER HANDLING OR STORAGE OF THE QC FLUIDS CONTRIBUTED TO THE HIGHER THAN EXPECTED VITROS TSH RESULTS, HOWEVER, THIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A NON-VITROS RANDOX QUALITY CONTROL (QC) FLUID WHEN TESTED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT LOT 7190 IN COMBINATION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. RANDOX QC VITROS TSH LOT 7190 RESULTS OF 0.221 AND 0.244 MIU/L VS. EXPECTED RESULT OF 0.16 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 FLUID AND NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427644 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER 7190 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown