BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 17683277 · Received September 5, 2023

    Report

    Report Number
    3007111389-2023-00149
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    July 26, 2023
    Report Date
    September 5, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JLW
    UDI-DI
    10758750000227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD IMMUNOASSAY PLUS QUALITY CONTROL (QC) FLUID, LOT 40430 WHEN TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT ON A VITROS XT 7600 INTEGRATED SYSTEM. AN ASSIGNABLE CAUSE OF THE EVENT WAS NOT DETERMINED. PRE-ANALYTICAL SAMPLE HANDLING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT POSSIBLE TO DETERMINE THE STABILITY OF THE QC VIAL USED. THEREFORE, IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD BE A CONTRIBUTOR TO THIS EVENT. THERE WERE TWO INSTRUMENTS AFFECTED AND INSTRUMENT PERFORMANCE IS NOT A LIKELY CONTRIBUTOR TO THE EVENTS. HOWEVER, IT CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR AS PRECISION TESTING TO ASSESS INSTRUMENT PERFORMANCE WAS NOT PERFORMED BY THE CUSTOMER.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD IMMUNOASSAY PLUS QUALITY CONTROL (QC) FLUID, LOT 40430 WHEN TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LEVEL 1 QC RESULTS ON INSTRUMENT J2: 0.250, 0.249, 0.250, 0.245, 0.249, 0.249 AND 250 MIU/L VS. THE EXPECTED RESULT OF 0.0367 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 LOWER THAN EXPECTED VITROS TSH RESULTS WERE FROM NON-PATIENT FLUID. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF SEVEN MDR¿S FOR THIS EVENT. SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVEN 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
    974209 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 7000 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown