BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11824828 · Received May 14, 2021

    Report

    Report Number
    8020790-2021-00124
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Report Date
    August 5, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN ITALY OF OBSERVING NEGATIVE RESULTS COMPARED TO ANOTHER TEST METHOD WHEN TESTING PATIENT SAMPLES USING VIDAS® SARS-COV-2 IGG (9COG) 60T (REF. (B)(4), BATCH 1008244900, EXPIRY DATE 29-JUL-2021). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. INVESTIGATION: A REVIEW OF THE BATCH HISTORY AND QUALITY CONTROL RECORDS DID NOT SHOW ANY ANOMALIES DURING THE MANUFACTURING, CONTROL, OR PACKAGING PROCESSES. CONTROL CHART ANALYSIS: A CONTROL CHARTS ANALYSIS WAS PERFORMED FOR FIVE INTERNAL SAMPLES (TWO WITH A NEGATIVE TARGET AND THREE WITH A POSITIVE ONE) ON SEVEN BATCHES OF VIDAS SARS COV-2 IGG INCLUDING THE LOT MENTIONED BY THE CUSTOMER (1008244900). ALL THE SAMPLES RESULTS COMPLY WITH THE SPECIFICATIONS AND THE CUSTOMER LOT IS WITHIN THE TREND COMPARED TO THE OTHER LOTS. TESTING: THREE INTERNAL SAMPLES WITH A POSITIVE TARGET GAVE RESULTS WITHIN SPECIFICATIONS WHEN TESTED ON VIDAS SARS COV-2 IGG ON RETAINED KIT OF CUSTOMER LOT 1008244900 AND LOT 1008364310. NO SIGNIFICANT DIFFERENCE OF THEIR ACTIVITY WAS OBSERVED COMPARED TO THOSE OBSERVED BEFORE THE BATCHES RELEASE. THERE IS NO EVOLUTION OVER TIME OF THESE BATCHES. TEST ON VIDAS SARS COV-2 IGG: THE CUSTOMER SUBMITTED THREE SAMPLES FOR THE INVESTIGATION, IDENTIFIED AS SAMPLES (B)(6). THE SAMPLES ID 192 AND 791 WERE TESTED ON RETAINED KIT OF VIDAS SARS COV-2 IGG BATCH 1008244900. BOTH GAVE NEGATIVE RESULTS, RESPECTIVELY 0.26 TV AND 0.50 TV. IT WAS NOT POSSIBLE TO TEST THE SAMPLE 310 BECAUSE ITS VOLUME WAS TOO LOW. THE RESULT OBTAINED BY THE CUSTOMER WAS REPRODUCED ON SAMPLE 192 WITH A SIMILAR INDEX. TEST ON VIDAS SARS COV-2 IGM: THE SAMPLES ID (B)(6) WERE TESTED ON VIDAS SARS COV-2 IGM BATCH 1008141730 (RETAIN KIT) AND BOTH GAVE NEGATIVE RESULTS, RESPECTIVELY 0.05 TV, 0.12 TV, AND 0.32 TV. *COMPETITOR METHOD RESULTS* THE PATIENT SAMPLES WERE TESTED USING A SARS COV-2 COMPETITOR METHOD (FROM EUROIMMUN). THE SAMPLES ID (B)(6) GAVE A NEGATIVE RESULT WITH ANTI-SARS-COV-2 ELISA IGG REF. (B)(4) (WITH RESPECTIVELY A RATIO OF 0.50 AND 0.37) AND THE SAMPLE ID (B)(6) GAVE A DOUBTFUL INTERPRETATION (WITH A RATIO OF 0.94). THE SAMPLES WERE ALSO TESTED WITH AN IN-HOUSE WESTERN BLOT, USING THE SAME MAIN RAW MATERIALS AS THOSE USED IN THE MANUFACTURING OF VIDAS SARS COV-2 IGG ASSAY (RBD ANTIGEN AND CONJUGATE) AND USING A NUCLEOCAPSID ANTIGEN AND AN EXTERNAL RBD PROTEIN. THE REVELATION WERE DONE USING HUMAN IMMUNOGLOBULIN IGA, IGM AND IGG. THE SAMPLE (B)(6) SHOWED TO HAVE MAINLY AN IMMUNE REACTIVITY OF IGG ANTIBODIES AGAINST NUCLEOCAPSID ANTIGEN. THERE IS ALSO A WEAK IMMUNE REACTIVITY OF IGA ANTIBODIES AGAINST NUCLEOCAPSID ANTIGEN. REGARDING THE IMMUNE REACTIVITY OF IGG ANTIBODIES AGAINST RBD ANTIGEN, THE INTENSITY IS COMPARABLE (SLIGHTLY LOWER) TO THE REACTIVITY OF AN INTERNAL SAMPLE KNOWN TO BE EQUIVOCAL ON VIDAS SARS COV-2 IGG (0.97 TV). THIS RESULT COULD EXPLAIN THE NEGATIVE RESULT OBSERVED WITH EUROIMMUN METHOD. THE SAMPLE (B)(6) SHOWED TO HAVE A VERY HIGH IMMUNE REACTIVITY OF IGG ANTIBODIES AGAINST NUCLEOCAPSID ANTIGEN. THERE IS ALSO A WEAK IMMUNE REACTIVITY OF IGA ANTIBODIES AGAINST NUCLEOCAPSID ANTIGEN. THE IMMUNE REACTIVITY OF IGG ANTIBODIES AGAINST RBD ANTIGEN, THE INTENSITY IS COMPARABLE TO THE REACTIVITY OF AN INTERNAL SAMPLE KNOWN TO BE EQUIVOCAL ON VIDAS SARS COV-2 IGG (0.97 TV). THE IMMUNE REACTIVITY OF IGA AND IGM ANTIBODIES AGAINST RBD ARE VERY LOW. THIS RESULT COULD EXPLAIN THE NEGATIVE RESULT OBSERVED WITH EUROIMMUN METHOD. CONCLUSION: ACCORDING TO THE IN-HOUSE WESTERN BLOT METHOD, IT SEEMS THAT THESE SAMPLES SHOULD HAVE A PARTICULAR SEROLOGICAL PROFILE WITH MAINLY IGG ANTIBODIES AGAINST NUCLEOCAPSID PROTEIN AND AN IGG RESPONSE AGAINST RBD PROTEIN EITHER LOWER THAN AN EQUIVOCAL SAMPLE (SAMPLE (B)(6)) OR JUST BELOW THE POSITIVE THRESHOLD OF VIDAS SARS COV-2 IGG METHOD (REF. (B)(4)). THIS PROFILE MIGHT EXPLAIN THE DISCREPANT RESULTS BETWEEN METHODS DUE TO THEIR FORMAT (GLOBAL DETECTION OF HUMAN IMMUNOGLOBULINS OR SEPARATE DETECTION; DETECTION OF ANTIBODIES AGAINST NUCLEOCAPSID PROTEIN, SPIKE PROTEIN OR RBD ANTIGEN). IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS SARS COV-2 IGG REF. (B)(4) AT THE SECTION LIMITATIONS OF THE METHOD: RESULTS OBTAINED USING SAMPLES FROM SARS-COV-2 INFECTED PATIENTS MUST BE INTERPRETED WITH CAUTION. THE INDIVIDUAL IMMUNE RESPONSE FOLLOWING SARS-COV-2 INFECTION VARIES CONSIDERABLY AND MIGHT GIVE DIFFERENT RESULTS WITH ASSAYS FROM DIFFERENT MANUFACTURERS. RESULTS OF ASSAYS FROM DIFFERENT MANUFACTURERS SHOULD NOT BE USED INTERCHANGEABLY. ACCORDING TO THE INVESTIGATION, THERE IS NO RECONSIDERATION OF VIDAS SARS COV-2 IGG REF. (B)(4) LOT 1008244900.

    Description of Event or Problem · 1

    ON (B)(6) 2021, A CUSTOMER FROM (B)(6) REPORTED TO BIOM¿RIEUX THAT THEY HAVE OBTAINED DISCREPANT RESULTS (POTENTIAL FALSE NEGATIVE RESULT) WITH THE PRODUCT VIDAS¿ SARS-COV-2 IGG (REF 423834, BATCH 1008244900, EXPIRY DATE 29-JUL-2021) COMPARED TO ANOTHER METHOD (ROCHE) WITH TWO PATIENTS SAMPLES. THE CUSTOMER STATED THAT TWO PATIENTS SAMPLES (WHO RECEIVED TWO DOSES OF VACCINE) WERE TESTED WITH TWO DIFFERENT METHODS, THE RESULTS WERE AS FOLLOWS: PATIENT 1: VIDAS: RESULT IGG = 0.21 (NEGATIVE INTERPRETATION). ROCHE: TOTAL ANTIBODIES RESULT (IGM+IGG+IGA) = 4.32 U/ML (POSITIVE INTERPRETATION  CUT OFF = 0.8). PATIENT 2: VIDAS: RESULT IGG = 0.82 (NEGATIVE INTERPRETATION). ROCHE: TOTAL ANTIBODIES RESULT (IGM+IGG+IGA) = 50 U/ML (POSITIVE INTERPRETATION  CUT OFF = 0.8). IT WAS EXPLAINED TO THE CUSTOMER THAT ROCHE METHOD DETECTS NOT ONLY IGG SPIKE BUT ALSO IGA AND IGM, SO ITS NOT POSSIBLE TO KNOW WHAT IS THE ANTIBODY FOUND. NO MORE DETAILS HAVE BEEN PROVIDED REGARDING THE CLINICAL CONTEXT, THE CUSTOMER DIDNT REPORT ANY PATIENT HEALTH IMPACT. A BIOM¿RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724819 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008244900

    Patients

    Seq Age Sex Outcome Treatment
    1