BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT

    MDR report key: 11601934 · Received April 1, 2021

    Report

    Report Number
    1319681-2021-00038
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 2, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT, FALSE REACTIVE VITROS SARS-COV-2 ANTIGEN (CV2AG) RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENTS WHEN TESTED USING VITROS CV2AG LOT 0015 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT COMPARED TO PCR RESULTS FOR THE PATIENTS. THE MOST LIKELY CAUSE OF THE FALSE REACTIVE VITROS CV2AG RESULTS FOR THE PATIENTS IS THE USE OF NATM-02 (MANUFACTURER: SHANGHAI IVEN MEDICAL TECHNOLOGY CO., LTD) AS A VTM FOR NASOPHARYNGEAL SAMPLES. DESPITE ACKNOWLEDGING THE NATM-02 VTM WAS THE WRONG VTM SENT FROM ANOTHER CUSTOMER SITE, THE CUSTOMER USED THE VTM TO TEST PATIENT 1 AND PATIENT 2 USING THE VITROS CV2AG REAGENT ASSAY. THE NATM-02 VTM IS NOT A RECOMMENDED VTM AS PER THE VITROS CV2AG IFU AND THE CUSTOMER DID NOT PERFORM VALIDATION TESTING TO VERIFY ACCEPTABLE VTM PERFORMANCE WITH THE VITROS CV2AG REAGENT ASSAY PRIOR TO THE TESTING OF PATIENT 1 AND PATIENT 2. FURTHERMORE, FALSE REACTIVE VITROS CV2AG RESULTS WERE OBTAINED WHEN THE NATM-02 VTM WAS TESTING WITHOUT PATIENT/QC FLUIDS ADDED. THE VITROS CV2AG IFU STATES: CERTAIN TRANSPORT MEDIA, INCLUDING THE REMEL M4RT, HAVE BEEN REPORTED TO AFFECT OTHER ANALYTES AND TESTS. FALSE POSITIVE RESULTS FOR SARS-CO-2 HAVE BEEN OBSERVED IN SOME TESTS WITH USE OF SOME TRANSPORT MEDIA, INCLUDING THE REMEL M4RT VIRAL TRANSPORT MEDIA. EMAIL ADDRESS FOR CONTACT OFFICE IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTRE (TSC) TO REPORT DISCORDANT, REACTIVE VITROS SARS-COV-2 ANTIGEN (CV2AG) RESULTS OBTAINED FROM TWO DIFFERENT PATIENTS WHEN TESTED USING VITROS CV2AG LOT 0015 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO A NEGATIVE NON-VITROS (PCR) RESULTS FOR THE PATIENTS. PATIENT 1, VITROS CV2AG RESULT OF 2.28 S/C (REACTIVE) VERSUS A NEGATIVE PCR RESULT. PATIENT 2, VITROS CV2AG RESULT OF 2.06 S/C (REACTIVE) VERSUS A NEGATIVE PCR RESULT. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS CV2AG REACTIVE RESULTS WERE REPORTED FROM THE LABORATORY TO A PHYSICIAN BUT NO TREATMENT WAS ALTERED, INITIATED, OR STOPPED BASED ON THE REPORTED RESULTS. CORRECTED REPORTS WERE LATER ISSUES FOR BOTH PATIENTS STATING THE NEGATIVE PCR RESULTS. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4). THIS REPORT IS NUMBER 2 OF 2 MDRS FOR THIS EVENT. TWO (2) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 2 DEVICES WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499653 VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT IN VITRO DIAGNOSTICS QKP ORTHO-CLINICAL DIAGNOSTICS 0015

    Patients

    Seq Age Sex Outcome Treatment
    1