BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT

    MDR report key: 11169266 · Received January 14, 2021

    Report

    Report Number
    1319681-2021-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 13, 2020
    Report Date
    March 11, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO UPDATE THE LIKELY ASSIGNABLE CAUSE FOR THE FALSE REACTIVE VITROS SARS COV-2 ANTIGEN RESULTS TO BE DUE TO AN ISSUE WITH THE PERFORMANCE OF THE REMEL M4RT. A FOLLOW UP WITH THE CUSTOMER AFTER THE INITIAL MDR WAS SENT IDENTIFIED THE CUSTOMER WAS USING REMEL M4RT VTM. 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 ((B)(4)) WAS SENT TO ALL CONSIGNEES ON 12 FEBRUARY 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(B)(4).

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO UPDATE ASSIGNABLE CAUSE TO INCLUDE AN ISSUE WITH THE PERFORMANCE OF THE REMEL M4RT AS A LIKELY CAUSE OF THE FALSE REACTIVE RESULTS. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4). THIS REPORT IS NUMBER ONE 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 NON-REACTIVE AND DISCORDANT REACTIVE VITROS SARS COV 2 ANTIGEN (CV2AG) RESULTS WERE OBTAINED FROM SAMPLES FROM MULTIPLE DIFFERENT PATIENTS WHEN TESTED USING VITROS CV2AG LOT 0014 ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS A DEFINITIVE CAUSE OF THE DISCORDANT FALSE NON-REACTIVE AND THE DISCORDANT FALSE REACTIVE VITROS CV2AG RESULTS WAS NOT DETERMINED. DISCORDANT VITROS CV2AG RESULTS WERE OBTAINED ON (B)(6) 2020, AND (B)(6) 2021, THEREFORE IT IS POSSIBLE THAT POTENTIAL CAUSES OF THE EVENTS VARIED BETWEEN EACH DATE. AN ISSUE WITH THE CUSTOMER¿S VITROS 5600 INTEGRATED SYSTEMS CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS THE RESULTS FOR PATIENTS 2, 3, 5 AND 11 WERE DISCORDANT WHEN COMPARED TO VITROS CV2AG FROM THE CUSTOMER¿S OTHER VITROS 5600 INTEGRATED SYSTEM. AN ORTHO FE WAS DUE TO VISIT THE CUSTOMER SITE TO VERIFY THE PERFORMANCE OF THE INSTRUMENTS ON (B)(6) 2021. NO INFORMATION WAS PROVIDED REGARDING THE HANDLING OF THE NASOPHARYNGEAL PATIENT SAMPLES, THEREFORE A PATIENT SAMPLE HANDLING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. A VITROS CV2AG LOT 0014 REAGENT ISSUE IS AN UNLIKELY CONTRIBUTOR TO THE EVENT, AS QC RESULTS AROUND THE TIME OF THE DISCORDANT VITROS CV2AG RESULTS WERE ACCEPTABLE. ADDITIONALLY, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS CV2AG LOT 0014. A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED BOTH DISCORDANT NON-REACTIVE AND REACTIVE VITROS SARS COV 2 ANTIGEN (CV2AG) RESULTS OBTAINED FROM SAMPLES FROM MULTIPLE DIFFERENT PATIENTS WHEN TESTED USING VITROS CV2AG LOT 0014 ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. THE RESULTS WERE DISCORDANT COMPARED TO PCR RESULTS FROM THE SAME PATIENT SAMPLES. ADDITIONALLY, VITROS CV2AG RESULTS WERE ALSO DISCORDANT AGAINST ALTERNATIVE VITROS CV2AG RESULTS FOR THE SAME PATIENTS IN SOME CASES. FALSE NON-REACTIVE VITROS CV2AG RESULTS: PATIENT 3, VITROS CV2AG RESULT OF 0.97 S/C (NON-REACTIVE) VERSUS A VITROS CV2AG RESULT OF 1.01 S/C (REACTIVE) AND A POSITIVE PCR RESULT. PATIENT 6, VITROS CV2AG RESULTS OF 0.90, 0.34 S/C (NON-REACTIVE) VERSUS A POSITIVE PCR RESULT. PATIENT 7, VITROS CV2AG RESULTS OF 0.87, 0.41 S/C (NON-REACTIVE) VERSUS A POSITIVE PCR RESULT. PATIENT 8, VITROS CV2AG RESULTS OF 0.69, 0.61 S/C (NON-REACTIVE) VERSUS A POSITIVE PCR RESULT. PATIENT 9, VITROS CV2AG RESULTS OF 0.59, 0.40 S/C (NON-REACTIVE) VERSUS A POSITIVE PCR RESULT. PATIENT 11, VITROS CV2AG RESULT OF 0.73 S/C (NON-REACTIVE) VERSUS A VITROS CV2AG RESULT OF 1.23 S/C (REACTIVE) AND A POSITIVE PCR RESULT. FALSE REACTIVE VITROS CV2AG RESULTS: PATIENT 2, VITROS CV2AG RESULT OF 1.08 S/C (REACTIVE) VERSUS A NEGATIVE PCR RESULT. PATIENT 5, VITROS CV2AG RESULT OF 1.42 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 RESULTS WERE NOT REPORTED FROM THE LABORATORY TO A PHYSICIAN AND PATIENT MANAGEMENT WAS NOT INFLUENCED BASED ON THE VITROS RESULTS AS THE VITROS CV2AG REAGENT ASSAY WAS UNDER VALIDATION AT THE CUSTOMER SITE. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE 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
    72086 VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT IN-VITRO DIAGNOSTIC QKP ORTHO-CLINICAL DIAGNOSTICS 0014

    Patients

    Seq Age Sex Outcome Treatment
    1