BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT

    MDR report key: 11207507 · Received January 21, 2021

    Report

    Report Number
    1319681-2021-00006
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 28, 2020
    Report Date
    March 10, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 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 DETERMINED THAT THE CUSTOMER WAS USING MULTIPLE VIRAL TRANSPORT MEDIUMS (VTM) THAT INCLUDED 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 #1319681-02/18/2021-001-C ((B)(4)).

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL MDR WAS CREATED TO UPDATE THE ASSIGNABLE CAUSE TO AN ISSUE WITH THE PERFORMANCE OF THE REMEL M4RT AS THE LIKELY CAUSE OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (ORTHO) COMPLAINT NUMBERS (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE DISCORDANT REACTIVE VITROS SARS COV 2 ANTIGEN (CV2AG) RESULT WAS OBTAINED A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS CV2AG LOT 0014 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A NEGATIVE PCR RESULT AND A NON-REACTIVE VITROS CV2AG RESULT OBTAINED FROM REPEAT TESTING OF THE PATIENT SAMPLE. THE ASSIGNABLE CAUSE OF THE DISCORDANT FALSE REACTIVE VITROS CV2AG RESULT WAS CONCLUDED TO BE PRE-ANALYTICAL SAMPLE HANDLING. THE CUSTOMER REPORTED THAT THEY MIX THE SAMPLE & EXTRACTION BUFFER BY INVERSION. PER THE CV2AG INSTRUCTIONS FOR USE, IT IS RECOMMENDED TO VORTEX THE SAMPLE FOR 3-5 SECONDS. THE CUSTOMER WILL TAKE ACTION TO ENSURE THE ALL LABORATORY OPERATORS VORTEX SAMPLES DURING THE EXTRACTION STEP FROM NOW ON. A VITROS CV2AG LOT 0014 REAGENT ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT, AS QC RESULTS ON THE DATE 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. THERE WAS NO INDICATION OF AN INSTRUMENT ISSUE. HOWEVER, AN ORTHO FIELD ENGINEER (FE) WENT ON SITE PER REQUEST OF THE CUSTOMER AND PERFORMED SERVICE ACTIONS TO THE MICROWELL INCUBATOR, SIGNAL REAGENT SUBSYSTEM, WELL WASH, SAMPLE AND REAGENT METERING SUBSYSTEMS. AS SERVICE ACTIONS WERE PERFORMED, AN INSTRUMENT ISSUE CANNOT DEFINITIVELY RULED OUT AS A POTENTIAL CONTRIBUTOR TO THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A NON-REPRODUCIBLE DISCORDANT REACTIVE VITROS SARS COV 2 ANTIGEN (CV2AG) RESULT WAS OBTAINED A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS CV2AG LOT 0014 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A NEGATIVE PCR RESULT AND A NON-REACTIVE VITROS CV2AG RESULT OBTAINED FROM REPEAT TESTING OF THE PATIENT SAMPLE. VITROS CV2AG = REACTIVE (1.37 S/C) VERSUS EXPECTED NON-REACTIVE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE FALSE REACTIVE VITROS CV2AG RESULT WAS REPORTED FROM THE LABORATORY TO A PHYSICIAN. THE LABORATORY ISSUED A CORRECTED RESULT OF NEGATIVE AS PER PCR RESULT. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107635 VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT IN-VITRO DIAGNOSTIC QKP ORTHO-CLINICAL DIAGNOSTICS 0014

    Patients

    Seq Age Sex Outcome Treatment
    1