BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 10276458 · Received July 15, 2020

    Report

    Report Number
    8020790-2020-00057
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    December 18, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN (B)(6) REGARDING FALSE NEGATIVE RESULTS FOR A PATIENT NASOPHARYNGEAL SAMPLE IN ASSOCIATION WITH THE VIDAS¿ SARS-COV-2 IGG (9COG) 60T (REF. 423834, LOT 1008090900). THE CUSTOMER TESTED THE SAMPLE ON THREE (3) ALTERNATIVE METHODS AND THE RESULTS WERE POSITIVE. INTERNAL SAMPLES WERE TESTED ON VIDAS SARS COV-2 LOT 1008090900 / 210512-0 (RETAIN), AND GAVE THE EXPECTED INTERPRETATION. THE COMPLAINTS LABORATORY HAS SUBSCRIBED TO EXTERNAL QUALITY ASSESSMENT PROGRAMS AND QUALITY CONTROL SAMPLES WERE TESTED ON VIDAS¿ SARS COV-2 IGG DURING THESE CHALLENGES (CTCB AND CAP SURVEY). ACCORDING TO THE FIRST OUTCOMES RECEIVED, ALL THE RESULTS WERE COMPLIANT TO EXPECTATIONS. THE PATIENTS SAMPLE WAS TESTED ON VIDAS¿ SARS COV-2 IGG LOT 1008090900 / 210512-0 (RETAIN). THE RESULT WAS NEGATIVE (0.80 VT) WITH AN INDEX SIMILAR TO THE TEST VALUE (0.80 AND 0.82 VT) OBSERVED BY THE CUSTOMER. THE SAMPLE WAS ALSO VIDAS¿ SARS COV-2 IGM NEGATIVE. THE LAB REPRODUCED THE CUSTOMERS NEGATIVE RESULT; HOWEVER, THE SAMPLE WAS FOUND POSITIVE WHEN TESTED USING A COMPETITOR METHOD AND AN IN-HOUSE WESTERN BLOT METHOD. THE IN-HOUSE WESTERN BLOT USED THE SAME MAIN RAW MATERIALS AS THOSE USED IN THE MANUFACTURING OF VIDAS¿ SARS COV-2 IGG ASSAY (RBD ANTIGEN AND CONJUGATE). THE SAMPLE SHOWED TO HAVE SPECIFIC BAND AGAINST RBD ANTIGEN WITH A REVELATION ON IGG AND IGM LEADING TO A POSITIVE INTERPRETATION. THE HYPOTHESIS COULD BE IGG ANTIBODIES LEVEL JUST ABOVE THE POSITIVE THRESHOLD OF VIDAS¿ SARS COV-2 IGG ASSAY. IT IS MENTIONED IN VIDAS SARS COV-2 IGG PACKAGE INSERT REF.423834, AT SECTION SENSITIVITY, THE FOLLOWING INFORMATION: "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. THE INVESTIGATION CONCLUDES THAT THIS LOT IS STILL WITHIN PERFORMANCE CLAIMS AND THERE IS NO QUESTIONING OF THE PERFORMANCE OF VIDAS¿ SARS COV-2 IGG LOT 1008090900 / 210512-0.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF FALSE NEGATIVE RESULTS FOR A PATIENT NASOPHARYNGEAL SAMPLE IN ASSOCIATION WITH THE VIDAS¿ SARS-COV-2 IGG (9COG) 60T (REF. 423834, LOT 1008090900). THE PATIENT SAMPLE WAS FROM A HEALTHCARE WORKER DISPLAYING COUGH AND FLU-LIKE SYMPTOMS. THE PATIENT SAMPLE WAS TESTED TWICE IN AUTOMATIC MODE USING VIDAS¿ SARS-COV-2 IGG LOT 1008090900. BOTH TESTS OBTAINED NEGATIVE RESULTS WITH VALUES OF 0.82 AND 0.80 RESPECTIVELY. THE CUSTOMER ALSO TESTED THE PATIENT SAMPLE USING THE POLY-DTECH RAPID TESTS (IGG) AND MENARINI RAPID TESTS (IGG AND IGM). ALL RESULTS FOR BOTH TEST METHODS WERE POSITIVE. THE PATIENT SAMPLE WAS TESTED VIA THE ROCHE TEST METHOD AT A SEPARATE LABORATORY; A POSITIVE RESULT OF 12.93 WAS OBTAINED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOM¿RIEUX HAS INITIATED AN INTERNAL INVESTIGATION. 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
    742841 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008090900

    Patients

    Seq Age Sex Outcome Treatment
    1