BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT PACK

    MDR report key: 11331311 · Received February 16, 2021

    Report

    Report Number
    1319681-2021-00023
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 10, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO UPDATE ASSIGNABLE CAUSE TO BE AN ISSUE WITH THE PERFORMANCE OF THE REMEL M4RT. THE REMEL VTM WAS PREVIOUSLY REPORTED AS A POTENTIAL CONTRIBUTOR. ORTHO HAS DETERMINED IT IS POSSIBLE FOR THE REMEL M4RT VTM TO GENERATE HIGHER THAN EXPECTED SIGNAL/CUTOFF (S/C), WHICH MAY RESULT IN A FALSELY REACTIVE RESULT, EVEN IN THE ABSENCE OF A SPECIMEN SWAB. A COMMUNICATION (CL2021-064) WAS SENT TO ALL CONSIGNEES ON (B)(6) 2021 AND INFORMED CUSTOMERS TO DISCONTINUE USE OF REMEL M4RT VTM AND TRANSITION TO AN ALTERNATE MEDIA. THE VITROS SARS-COV-2 ANTIGEN INSTRUCTIONS FOR USE HAS BEEN UPDATED TO REMOVE REMEL M4RT VTM FROM THE INTENDED USE AND THE SPECIMENS RECOMMENDED SECTIONS. THE FDA WAS NOTIFIED OF THIS ISSUE ON 11 FEBRUARY 2021. PLEASE REFER TO REPORT #1319681-02/18/2021-001-C (RES87356).

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO UPDATE ASSIGNABLE CAUSE TO BE AN ISSUE WITH THE PERFORMANCE OF THE REMEL M4RT. IT WAS PREVIOUSLY REPORTED AS A POTENTIAL CONTRIBUTOR. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (ORTHO)COMPLAINT NUMBERS (B)(4) AND (B)(4). THIS REPORT IS NUMBER TWO OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT, REACTIVE VITROS SARS-COV-2 ANTIGEN (CV2AG) RESULTS WERE OBTAINED FROM THREE DIFFERENT PATIENT SAMPLES WHEN PROCESSED USING VITROS CV2AG REAGENT LOT 0014 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. BASED ON HISTORICAL QC RESULTS, A VITROS CV2AG LOT 0014 REAGENT PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS VITROS QC FLUID RESULTS PRIOR TO THE EVENT WERE ACCEPTABLE. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS CV2AG LOT 0014. THERE WAS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION. HOWEVER, DIAGNOSTIC PRECISION TESTING WAS NOT CONDUCTED ON THE INSTRUMENT AROUND THE TIME OF THE EVENT. THEREFORE, AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. THE TSC DISCUSSED SAMPLE PREPARATION (EXTRACTION PROCESS) AND CONFIRMED THE CUSTOMER IS FOLLOWING DIRECTIONS AS DOCUMENTED IN THE VITROS SARS-COV-2 ANTIGEN INSTRUCTIONS FOR USE. THE VIRAL TRANSPORT MEDIA BEING USED WAS REMEL M4RT LOT 183482, WHICH IS A NON-VITROS PRODUCT. COMPLAINT INVESTIGATION ((B)(4)) IS OPEN TO INVESTIGATE A POTENTIAL ISSUE WITH VITROS CV2AG RESULTS WHEN REMEL M4RT IS USED AS A VIRAL TRANSPORT MEDIUM (VTM) FOR NASOPHARYNGEAL SAMPLES. AN ISSUE WITH THE VTM USED BY THE CUSTOMER CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED DISCORDANT, REACTIVE VITROS SARS-COV-2 ANTIGEN (CV2AG) RESULTS FROM THREE DIFFERENT PATIENT SAMPLES WHEN PROCESSED USING VITROS CV2AG REAGENT LOT 0014 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1, VITROS CV2AG RESULT OF 1.02 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE. PATIENT 3, VITROS CV2AG RESULT OF 1.22 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE. PATIENT 4, VITROS CV2AG RESULT OF 1.37 S/C (REACTIVE) VERSUS THE EXPECTED RESULT OF NEGATIVE. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE DISCORDANT REACTIVE VITROS CV2AG RESULTS WERE NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO).COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232805 VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT PACK IN-VITRO DIAGNOSTIC QKP ORTHO-CLINICAL DIAGNOSTICS 0014

    Patients

    Seq Age Sex Outcome Treatment
    1