BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 17193237 · Received June 23, 2023

    Report

    Report Number
    3007111389-2023-00103
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 19, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    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 HAS DETERMINED THAT A LOWER THAN EXPECTED VITROS TSH 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 COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS TSH LOT 7020 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. PRECISION TESTING OF THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMED WHEN REQUESTED, 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. THE PRESENCE OF A SAMPLE INTERFERENT AS THE CAUSE OF THE LOWER THAN EXPECTED VITROS TSH RESULT IN THE SAMPLE FROM THE PATIENT IN QUESTION, THAT AFFECTS THE VITROS TSH METHOD AND NOT THE NON-VITROS ABBOTT METHOD, CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. INVESTIGATIVE TESTING WAS PERFORMED BY THE CUSTOMER FOR THE PRESENCE OF A SAMPLE SPECIFIC INTERFERENT, HOWEVER, THIS DID NOT INCLUDE THE USE OF SAMPLE BLOCKING TUBES TO DEFINITIVELY ESTABLISH THE PRESENCE OF A SAMPLE SPECIFIC INTERFERENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS TSH REAGENT LOT 7020.

    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 SAMPLE FROM A SINGLE PATIENT WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT TSH RESULT OF 0.43 MIU/L VERSUS THE EXPECTED RESULT OF 3.05 MIU/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. PATIENT SAMPLE RESULTS WERE NOT REPORTED FROM THE LABORATORY AND ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 602368.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279087 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS, INC. 1912997 7020 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown