BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT

    MDR report key: 11272515 · Received February 3, 2021

    Report

    Report Number
    3007111389-2021-00016
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    December 30, 2020
    Report Date
    March 10, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    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 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). CORRECTION TO THE MFG SITE REGISTRATION NUMBER: INITIALLY FILED AS 3007111389 AND SHOULD BE 1319681.

    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. THERE IS ALSO A CORRECTION TO THE MFG SITE REGISTRATION NUMBER AS DOCUMENTED IN H10. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4)3. THIS REPORT IS NUMBER 1 OF 3 MDR¿S FOR THIS EVENT. THREE (3) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 3 DEVICES WERE INVOLVED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT REACTIVE VITROS SARS COV-2 ANTIGEN (CV2AG) RESULTS WERE OBTAINED FROM MULTIPLE DIFFERENT PATIENT SAMPLES PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT LOT 0014 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO NEGATIVE PCR RESULTS FOR THE PATIENTS. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. HOWEVER, AN ISSUE WITH THE NON-VITROS, REMEL M4RT VTM IS A POSSIBLE CONTRIBUTOR TO THE EVENT. AS PART OF TROUBLESHOOTING, THE REMEL M4RT LOT 126001 VTM (TRANSPORT MEDIUM) WAS TESTED WITHOUT THE ADDITION OF A PATIENT OR QUALITY CONTROL FLUID AND UNEXPECTED, REACTIVE VITROS CV2AG RESULTS WERE OBTAINED. THE INVESTIGATION INTO A POTENTIAL ISSUE WITH THE REMEL M4RT VTMS REMAINS OPEN AND IT IS NOT POSSIBLE TO DETERMINE WHETHER A POTENTIAL ISSUE IS ISOLATED TO A SPECIFIC LOT OF VTM. 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 PREPARATION OF THE PATIENT SAMPLES FOR VITROS CV2AG TESTING CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT AS FOLLOWING THE OBSERVATION OF PATIENT SAMPLE PREPARATION, AN ORTHO LABORATORY SPECIALIST GUIDED THE CUSTOMER TOWARDS MIXING THE PATIENT SAMPLE SPECIMEN AS PER THE VITROS CV2AG INSTRUCTIONS FOR USE. THE ORTHO FIELD ENGINEER RECOMMENDED THE CUSTOMER MIX THE PATIENT SAMPLES USING A VORTEX FOR 3-5 SECONDS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DISCORDANT REACTIVE VITROS SARS COV-2 ANTIGEN (CV2AG) RESULTS OBTAINED FROM MULTIPLE DIFFERENT PATIENT SAMPLES PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE DISCORDANT WHEN COMPARED TO NEGATIVE PCR RESULTS FOR THE PATIENTS. PATIENT 2, VITROS CV2AG RESULT OF 1.46 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 3, VITROS CV2AG RESULT OF 1.01 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 4, VITROS CV2AG RESULT OF 1.34 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 5, VITROS CV2AG RESULT OF 1.03 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 6, VITROS CV2AG RESULT OF 1.03 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 7, VITROS CV2AG RESULT OF 1.59 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 8, VITROS CV2AG RESULT OF 1.09 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 9, VITROS CV2AG RESULT OF 1.27 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 10, VITROS CV2AG RESULT OF 1.29 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 11, VITROS CV2AG RESULT OF 1.89 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 12, VITROS CV2AG RESULT OF 1.75 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 13, VITROS CV2AG RESULT OF 1.53 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 14, VITROS CV2AG RESULT OF 2.67 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 15, VITROS CV2AG RESULT OF 1.31 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 16, VITROS CV2AG RESULT OF 1.05 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 17, VITROS CV2AG RESULT OF 1.57 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 18, VITROS CV2AG RESULT OF 1.07 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 19, VITROS CV2AG RESULT OF 1.35 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 20, VITROS CV2AG RESULT OF 1.03 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 21, VITROS CV2AG RESULT OF 1.23 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 22, VITROS CV2AG RESULT OF 1.45 S/C (REACTIVE) VERSUS THE PCR RESULT OF NEGATIVE. PATIENT 23, VITROS CV2AG RESULT OF 1.54 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. THE INITIAL FALSE REACTIVE VITROS CV2AG RESULTS FOR PATIENTS 2-6 WERE REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE FALSE REACTIVE RESULTS AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. FOLLOWING FURTHER DISCORDANT, FALSE REACTIVE VITROS CV2AG RESULTS FOR PATIENTS 7-23, THE CUSTOMER STOPPED USING THE VITROS CV2AG ASSAY TO REPORT PATIENT SAMPLE RESULTS. THIS REPORT IS NUMBER 1 OF 3 MDR¿S FOR THIS EVENT. THREE (3) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 3 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173688 VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT IN VITRO DIAGNOSTICS QKP ORTHO-CLINICAL DIAGNOSTICS 0014

    Patients

    Seq Age Sex Outcome Treatment
    1