BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11021197 · Received December 16, 2020

    Report

    Report Number
    8020790-2020-00136
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    March 16, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN SPAIN OF OBTAINING A NEGATIVE RESULT FOR A PATIENT SAMPLE USING VIDAS® SARS-COV-2 IGG (REF 423834, LOT 1008197250/210708-1) AS COMPARED WITH ROCHE METHOD (POSITIVE RESULT). AN INTERNAL BIOMERIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER¿S SAMPLE WAS NOT AVAILABLE TO PERFORM INVESTIGATIONAL TESTING. NO ANOMALIES WERE IDENTIFIED DURING THE MANUFACTURING, QUALITY CONTROL, AND PACKAGING PROCESSES ON VIDAS® SARS COV-2 IGG BATCH 1008197250 / 210708-1. CONTROL CHART ANALYSIS: ANALYSIS WAS CARRIED OUT USING FOUR (4) INTERNAL SAMPLES WITH POSITIVE TARGETS ON SEVEN (7) BATCHES OF VIDAS SARS COV-2 IGG (INCLUDING THE CUSTOMER¿S LOT). THE ANALYSIS SHOWED THAT THE SAMPLES WERE CONSISTENT WITH EXPECTATIONS AND THE PERFORMANCE COMPARED TO OTHER LOTS. TESTING: THE COMPLAINTS LABORATORY TESTED FOUR (4) INTERNAL SAMPLES (2 WITH A POSITIVE TARGET AND 2 WITH A NEGATIVE TARGET). THE SAMPLE RESULTS COMPLIED WITH THE EXPECTED SPECIFICATIONS AND DID NOT SHOW ANY SIGNIFICANT DIFFERENCE COMPARED TO THE RESULTS OBTAINED BEFORE BATCH RELEASE. THE LAB DID NOT OBSERVE ANY EVOLUTION OVER TIME OF VIDAS® SARS COV-2 IGG BATCH 1008197250 / 210708-1. THE COMPLAINTS LABORATORY ALSO TESTED SOME QUALITY CONTROL SAMPLES (2 POSITIVE AND ONE NEGATIVE) ON SEVERAL BATCHES OF VIDAS SARS COV-2 IGG INCLUDING VIDAS SARS COV-2 LOT 1008197250 / 210708-1. ALL THE RESULTS WERE COMPLIANT TO EXPECTED INTERPRETATION WITH SIMILAR LEVELS WHATEVER THE LOT. PER THE VIDAS SARS COV-2 IGG PACKAGE INSERT (REF.423834), SENSITIVITY SECTION STATES: "THE SENSITIVITY WAS DETERMINED BY INVESTIGATING 190 SAMPLES COLLECTED FROM 120 PATIENTS. INFECTION WITH SARS-COV-2 WAS CONFIRMED BY PCR TESTING. THE 190 SAMPLES WERE TESTED SINGLY USING THE VIDAS SARS-COV-2 IGG ASSAY ON THE VIDAS INSTRUMENT. THE SENSITIVITY EVALUATED IS 96.6% FOR SAMPLES COLLECTED AFTER 16 DAYS AFTER PCR POSITIVE RESULT." CONCLUSION: BIOMÉRIEUX DID NOT REPRODUCE THE VIDAS® SARS COV-2 IGG NEGATIVE RESULT WHEN TESTING POSITIVE INTERNAL SAMPLES AND POSITIVE QUALITY CONTROL SAMPLES ON VIDAS® SARS COV-2 IGG BATCH 1008197250 / 210708-1. ALL THE RESULTS COMPLIED WITH EXPECTATIONS. WITHOUT SUBMITTAL OF THE CUSTOMER'S SAMPLE, IT IS NOT POSSIBLE TO PURSUE FURTHER INVESTIGATION. SAMPLES CAN HAVE SEROLOGICAL PROFILES WITH VARYING ANTIBODY DISTRIBUTION (AGAINST EITHER NUCLEOCAPSID ANTIGEN, SPIKE PROTEIN OR RBD SUB DOMAIN). THIS KIND OF PROFILE MIGHT EXPLAIN THE DISCREPANT RESULTS OBSERVED BY THE CUSTOMER. THE ROCHE ANTI SARS COV-2 METHOD DETECTS ALL THE IG ANTIBODIES (IGA, IGM AND IGG) AGAINST NUCLEOCAPSID ANTIGEN. VIDAS SARS COV-2 ASSAYS IDENTIFY IG ANTIBODIES AGAINST A SUBDOMAIN OF SPIKE PROTEIN (RECEPTOR BINDING PROTEIN = RBD). THE PACKAGE INSERT OF VIDAS SARS COV-2 IGG REF. 423834 AT THE SECTION LIMITATIONS OF THE METHOD STATES: ¿RESULTS OBTAINED USING SAMPLES FROM SARS-COV-2 INFECTED PATIENTS MUST BE INTERPRETED WITH CAUTION. ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF VIDAS SARS COV-2 IGG REF. 423834 LOT 1008197250 / 210708-1.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT WHILE TESTING A PATIENT SAMPLE USING THE VIDAS® SARS-COV-2 IGG (9COG) 60T (REF. 423834, LOT 1008197250). PER THE CUSTOMER'S PROCEDURE, THEY FIRST PERFORM TOTAL ANTIBODIES TEST (IGG, IGM, IGA) WITH ROCHE'S REAGENT. IF THE RESULT IS POSITIVE, THE HOSPITAL PERFORMS ADDITIONAL TESTS WITH VIDAS SARS-COV-2 IGG AND IGM. IT WAS INDICATED THAT MOST OF THE CONCERNED CASES ARE PATIENTS WITH POSITIVE PCR RESULT FOR WHOM, AFTER 15 DAYS, THE TOTAL ANTIBODY INDEX BY THE ROCHE TECHNIQUE GAVE A POSITIVE RESULT, AND VIDAS SARS-COV-2 IGG AND IGM TESTS GIVE NEGATIVE RESULTS. THE CUSTOMER INDICATES THAT THEY ALSO USE AN IGG AND IGM IMMUNOCHROMATOGRAPHY TECHNIQUE. THE CURRENT COMPLAINT WAS RECORDED FOR ONE PATIENT TESTED WITH LOT 1008197250. THE FOLLOWING RESULTS WERE OBTAINED FOR THIS PATIENT : VIDAS SARS COV-2 IGG (LOT 1008197250 / 210708-1) : NEGATIVE RESULT 0.33 TV. VIDAS SARS COV-2 IGM (LOT 1008215740 / 210723-0): NEGATIVE RESULT 0.19 TV. ROCHE ANTI-SARS COV-2 (TOTAL ANTIBODIES DETECTION INCLUDING IGG, IGM, IGA): 36.48 (POSITIVE RESULT). THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE 423834 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, 423834-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423834.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488279 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008197250

    Patients

    Seq Age Sex Outcome Treatment
    1