BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11300933 · Received February 9, 2021

    Report

    Report Number
    8020790-2021-00008
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Report Date
    September 17, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN SERBIA REGARDING FALSE NEGATIVE RESULT FOR TWO (2) SEPARATE PATIENT SAMPLES WHEN USING VIDAS® SARS-COV-2 IGG (9COG) 60T (REF. (B)(4), LOT 1008344690 EXPIRY 24-SEP-2021) ON A NEW MINI VIDAS® INSTRUMENT, INSTALLED IN (B)(6) 2020. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: ACCORDING TO QUALITY CONTROL RECORDS, THERE IS NO ANOMALY HIGHLIGHTED DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES ON VIDAS SARS COV-2 IGG LOT 1008344690/210924-0. ANALYSIS WAS PERFORMED ON FOUR (4) INTERNAL SAMPLES WITH A POSITIVE TARGET ON SEVEN (7) BATCHES OF VIDAS SARS COV-2 IGG INCLUDING THE LOT MENTIONED BY CUSTOMER 1008344690/210924-0. THE ANALYSIS SHOWED THAT THE SAMPLES COMPLIED WITH THE EXPECTATIONS AND VIDAS SARS COV-2 IGG BATCH 1008344690/210924-0 WAS IN THE TREND COMPARED TO THE OTHER LOTS. THE COMPLAINTS LABORATORY TESTED FOUR (4) INTERNAL SAMPLES (3 WITH A POSITIVE TARGET AND 1 WITH A NEGATIVE TARGET). THE SAMPLES RESULTS COMPLIED WITH THE EXPECTED SPECIFICATIONS WITHOUT ANY SIGNIFICANT DIFFERENCE COMPARED TO THE RESULTS OBSERVED BEFORE THE BATCH RELEASE. NO EVOLUTION WAS OBSERVED OVER TIME OF VIDAS SARS COV-2 IGG BATCH 1008344690/210924-0. THE VIDAS SARS COV-2 IGG NEGATIVE RESULT WAS NOT REPRODUCED WHEN TESTING POSITIVE INTERNAL SAMPLES ON VIDAS SARS COV-2 IGG BATCH 1008344690/210924-0. ALL THE RESULTS COMPLIED WITH EXPECTATIONS. WITHOUT ANY CONCERNED SAMPLE AVAILABLE, IT WAS NOT POSSIBLE TO PURSUE FURTHER THE INVESTIGATION. THEREFORE, NO ROOT CAUSE WAS IDENTIFIED. DURING PAST INVESTIGATIONS, IT WAS OBSERVED ON SOME SAMPLES A PARTICULAR SEROLOGICAL PROFILE WITH A SPECIFIC ANTIBODIES DISTRIBUTION (AGAINST EITHER NUCLEOCAPSID ANTIGEN, SPIKE PROTEIN OR RBD SUB DOMAIN). THIS KIND OF PROFILE MIGHT EXPLAIN THE DISCREPANT RESULTS OBSERVED BY THE CUSTOMER. 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 DATA MENTIONED ABOVE, VIDAS SARS COV-2 IGG REF.(B)(4) LOT 1008344690/210924-0 IS MEETING ITS SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF OBTAINING A FALSE NEGATIVE RESULT FOR TWO (2) SEPARATE PATIENT SAMPLES WHEN USING VIDAS¿ SARS-COV-2 IGG (9COG) 60T (REF. 423834, LOT 1008344690 EXPIRY 24-SEP-2021) ON A NEW MINI VIDAS¿ INSTRUMENT, INSTALLED IN NOVEMBER 2020. 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. PATIENT "(B)(6)". VIDAS RESULT: 0.53 TV, NEGATIVE. SAMPLE SENT TO A DIFFERENT LAB TO TEST ON VIDAS. RESULT: 0.56, NEGATIVE (TESTED WITH THE SAME LOT 1008344690). PCR: POSITIVE. VIRCLIA IGG: 6.29, POSITIVE. THE CUSTOMER NOTED THAT BOTH OF THE PATIENTS DISPLAYED MILD CLINICAL SYMPTOMS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS INCIDENT HAVE LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOM¿RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200616 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008344690

    Patients

    Seq Age Sex Outcome Treatment
    1