BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11207685 · Received January 21, 2021

    Report

    Report Number
    8020790-2021-00003
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Report Date
    March 31, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    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 A FALSE NEGATIVE RESULT WHILE TESTING A PATIENT SAMPLE USING THE VIDAS® SARS-COV-2 IGG (REFERENCE # 423834, LOT # 1008366980).THE PATIENT WAS INFECTED WITH COVID-19 IN (B)(6). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: NO PATIENT SAMPLE WAS RETURNED BY THE CUSTOMER. REVIEW OF QUALITY CONTROL RECORDS SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. THE COMPLAINTS LABORATORY PERFORMED TESTS ON FOUR (4) INTERNAL SERA (TARGETS : 1.34 TV, 1.70 TV, 1.75 TV AND 2.23 TV). THE ANALYSIS WAS PERFORMED ON SEVEN (7) BATCHES INCLUDING THE BATCH MENTIONED BY THE CUSTOMER VIDAS SARS COV-2 IGG (LOT 1008366980/210928-0). ALL VALUES WERE WITHIN SPECIFICATIONS AND THE CUSTOMER'S LOT WAS IN THE TREND OF THE OTHER LOTS. AN ANALYSIS WAS CARRIED OUT ON FOUR (4) SAMPLES FROM THE ACTIVITY PANEL. ONE NEGATIVE (TARGET: 0.65 TV) AND THREE (3) POSITIVE (TARGETS: 1.75TV, 2.23TV AND 2.45 TV) WERE TESTED WITH VIDAS SARS COV-2 IGG (LOT 1008366980/210928-0). ALL RESULTS WERE WITHIN SPECIFICATIONS WITH SIMILAR RESULTS COMPARED TO THOSE OBTAINED BEFORE THE BATCH WAS RELEASED. THE COMPLAINTS LABORATORY IS SUBSCRIBED TO EXTERNAL QUALITY ASSESSMENT PROGRAMS. FOUR SAMPLES, ONE NEGATIVE AND THREE (3) POSITIVE SAMPLES WERE TESTED ON VIDAS SARS COV-2 IGG DURING THIS CHALLENGE. ACCORDING TO THE FIRST OUTCOMES RECEIVED, ALL THE RESULTS WERE COMPLIANT TO EXPECTATIONS. 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 CUSTOMER'S ISSUE WAS NOT REPRODUCED. FURTHER INVESTIGATION CANNOT BE PERFORMED WITHOUT ANY CONCERNED SAMPLES AVAILABLE. IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS SARS COV-2 IGG REF.423834 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 (LOT 1008366980/210928-0) IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT WHILE TESTING AN PATIENT SAMPLE USING THE VIDAS® SARS-COV-2 IGG (REFERENCE # 423834, LOT # 1008366980). THE PATIENT WAS INFECTED WITH COVID-19 IN (B)(6). VIDAS® SARS-COV-2 RESULTS: ON (B)(6) 2020 SAMPLE PATIENT (B)(6): 1:47PM: SARS COV-2 IGG = 0.69 TV => NEGATIVE; 1:56PM : SARS COV-2 IGM = 2.90 TV => POSITIVE; 3:00 PM RETEST SARS COV-2 IGG = 0.75 TV => STILL NEGATIVE. ALTERNATE METHOD RESULTS: RAPID TEST: IGG AND IGM POSITIVE. SYNEVO (CHEMILUMINESCENT METHOD): ON (B)(6) 2020 IGG = 2.02 (< 1.4 NEGATIVE / > OR =1 .4 POSITIVE)=> POSITIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY 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
    106876 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008366980

    Patients

    Seq Age Sex Outcome Treatment
    1