BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS SARS-COV-2 ANTIGEN REAGENT

    MDR report key: 11285878 · Received February 5, 2021

    Report

    Report Number
    1319681-2021-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 8, 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. IT WAS DETERMINED THAT 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 (CL2021-064) 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 #(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 EVENT. IT WAS PREVIOUSLY REPORTED AS A POTENTIAL CONTRIBUTOR. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A DISCORDANT REACTIVE VITROS SARS COV-2 ANTIGEN (CV2AG) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED USING VITROS CV2AG LOT 0014 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS DISCORDANT WHEN COMPARED TO NEGATIVE PCR RESULT FOR THE PATIENT. A DEFINITIVE CAUSE OF THE EVENT HAS NOT BEEN ESTABLISHED. HOWEVER, AN ISSUE WITH THE NON-VITROS, REMEL M4RT VTM IS A POSSIBLE CONTRIBUTOR TO THE EVENT. AS PART OF TROUBLESHOOTING, HIGHER THAN EXPECTED VITROS CV2AG RESULTS WERE OBTAINED WHEN DIFFERENT LOTS OF REMEL M4RTVTM WERE TESTED WITHOUT THE ADDITION OF A PATIENT OR QC FLUID AT THE CUSTOMER SITE AND IN-HOUSE BY ORTHO R & D. THE INVESTIGATION INTO A POTENTIAL ISSUE WITH THE REMEL M4RT VTMS REMAINS OPEN ((B)(4)). A VITROS CV2AG LOT 0014 REAGENT ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT, AS QC RESULTS AROUND THE TIME OF THE EVENT WERE WITHIN ACCEPTABLE GUIDELINES. 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. AN INSTRUMENT ISSUE IS AN UNLIKELY CONTRIBUTOR TO THE EVENT, AS DIAGNOSTIC PRECISION TESTING ON THE CUSTOMER¿S VITROS 5600 INTEGRATED SYSTEM INDICATED ACCEPTABLE INSTRUMENT PERFORMANCE. AN ISSUE WITH THE PRE-ANALYTICAL HANDLING OF PATIENT SAMPLES IS AN UNLIKELY CONTRIBUTOR TO THE EVENT. AN ORTHO LS INDICATED THE CUSTOMER WAS FOLLOWING THE VITROS CV2AG IFU FOR SPECIMEN COLLECTION AND PREPARATION UPON OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT A DISCORDANT, REACTIVE VITROS SARS-COV-2 ANTIGEN (CV2AG) RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED USING VITROS CV2AG LOT 0014 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT VITROS CV2AG RESULT OF 1.19 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE FALSE REACTIVE VITROS CV2AG RESULT WAS NOT REPORTED FROM THE LABORATORY. 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. COMPLAINT NUMBER (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186631 VITROS IMMUNODIAGNOSTICS PRODUCTS SARS-COV-2 ANTIGEN REAGENT IN VITRO DIAGNOSTIC QKP ORTHO-CLINICAL DIAGNOSTICS 0014

    Patients

    Seq Age Sex Outcome Treatment
    1