BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 16548645 · Received March 15, 2023

    Report

    Report Number
    0001319681-2023-00016
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 11, 2023
    Report Date
    March 15, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KHO
    UDI-DI
    10758750000272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONCLUDED THAT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNI-IMMUNE CONTROL, LOT 2302 TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED. AN ORTHO FIELD ENGINEER (FE) WENT ON SITE AND DISCOVERED THE CONNECTIONS TO THE SIGNAL REAGENT (SR) DISPENSE PROBES WERE VERY LOOSE. THE ORTHO FE REPLACED THE SR DISPENSE PROBES AND VERIFIED ALL INCUBATOR, SR AND WELL WASH ALIGNMENTS. ONCE THE SERVICE ACTIONS WERE COMPLETED, AFTER THE SERVICE ACTIONS WERE PERFORMED, ACCEPTABLE VITROS TSH PERFORMANCE WAS OBTAINED.

    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 SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNI-IMMUNE CONTROL, LOT 2302 TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. MAS LEVEL 1 CONTROL FLUID VITROS TSH RESULTS OF 0.079, 0.044, 0.075 AND 0.038 MIU/L VS. THE BASELINE MEAN VALUE OF 0.135 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 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 601121.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711347 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS, INC. 1922814 10758750000272

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown