BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11987372 · Received June 11, 2021

    Report

    Report Number
    8020790-2021-00137
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Report Date
    October 26, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED NEGATIVE RESULTS ON SEVERAL PATIENTS¿ SAMPLES WHEN TESTING THEM WITH VIDAS® SARS COV-2 IGG (REF.423834 LOT 1008630790). SAMPLES WERE POSITIVE USING A COMPETITOR METHOD (ROCHE ELECSYS, COBAS INSTRUMENT). NO CLINICAL HISTORY AVAILABLE (CONTACT, INFECTION OR VACCINATION). AN INTERNAL INVESTIGATION WAS PERFORMED. ONLY ONE SAMPLE WAS SUBMITTED TO THE COMPLAINTS LABORATORY FOR TESTING, (B)(6). ACCORDING TO QUALITY CONTROL RECORD, THERE IS NO ANOMALY HIGHLIGHTED DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES THE LOT. CONTROL CHART ANALYSIS WAS CARRIED OUT FOR FIVE INTERNAL SAMPLES WITH (2 WITH A NEGATIVE TARGET AND 3 WITH A POSITIVE TARGET), USING SEVEN (7) BATCHES OF VIDAS SARS COV-2 IGG INCLUDING THE CUSTOMER¿S LOT. ALL THE SAMPLES RESULTS COMPLY WITH THE SPECIFICATIONS, AND THE CUSTOMER¿S LOT WAS CONSISTENT COMPARED TO THE OTHER. TESTING VIDAS® SARS COV-2 IGG: FOUR INTERNAL SAMPLES (1 NEGATIVE TARGET AND 3 WITH A POSITIVE TARGET) WERE TESTED ON THE FOUR LOTS OF VIDAS® SARS COV-2 IGG, INCLUDING THE CUSTOMER¿S LOT. THE NEGATIVE SAMPLE GAVE NEGATIVE RESULTS, AND THE POSITIVE SAMPLES WERE POSITIVE WHEN TESTED ON THE FOUR LOTS. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE RESULTS OBSERVED BEFORE THE BATCHES RELEASE. EXTERNAL LABORATORY RESULTS: THE PATIENT SAMPLE WAS SENT TO AN EXTERNAL LABORATORY (B)(6) FOR ADDITIONAL TESTING USING THE TEST NOVALISA SARS COV-2 IGM NOVATEC. THE SAMPLE GAVE A NEGATIVE RESULT FOR IGM ANTI SARS COV-2. CONCLUSION: BIOMÉRIEUX DID NOT REPRODUCE THE CUSTOMER¿S ISSUE (NAMELY A NEGATIVE INTERPRETATION) WHEN TESTING POSITIVE INTERNAL SAMPLES ON THE LOT OF VIDAS® SARS COV-2 IGG MENTIONED BY THE CUSTOMER. THE SAMPLE SUBMITTED BY THE CUSTOMER GAVE A NEGATIVE INTERPRETATION WHEN TESTING IN AN EXTERNAL LABORATORY USING THE METHOD NOVALISA SARS COV-2 IGM NOVATEC. ACCORDING TO THE INVESTIGATIONS OUTCOMES, THE DISCREPANT RESULTS BETWEEN METHODS COULD BE LINKED TO THE SAMPLE PROFILE AND THE ANTIBODIES LEVEL CLOSE TO THE THRESHOLD. SARS COV-2 ANTIBODIES METHODS HAVE DIFFERENT 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.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 M DIFFERENT MANUFACTURERS. RESULTS OF ASSAYS FROM DIFFERENT MANUFACTURERS SHOULD NOT BE USED INTERCHANGEABLY. ACCORDING TO THE INFORMATION MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF VIDAS SARS COV-2 IGG REF.423834 FOR 1008630790.

    Description of Event or Problem · 0

    PRODUCT DESCRIPTION: VIDAS® SARS-COV-2 IGG (9COG) IS AN AUTOMATED QUALITATIVE ASSAY FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS, FOR THE DETECTION OF IMMUNOGLOBULIN G (IGG) SPECIFIC FOR SARS-COV-2 IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME LINKED FLUORESCENT ASSAY) TECHNIQUE. THIS ASSAY IS INTENDED FOR USE AS AN AID TO DETERMINE IF INDIVIDUALS MAY HAVE BEEN EXPOSED AND INFECTED BY THIS VIRUS AND IF THEY HAVE MOUNTED A SPECIFIC ANTI-SARS-COV-2 IGG IMMUNE RESPONSE. INTERPRETATION OF RESULTS ACCORDING TO TEST VALUE (I) IS AS FOLLOWS: INDEX INTERPRETATION I < 1.00 : NEGATIVE I = 1.00 : POSITIVE ISSUE DESCRIPTION: ON (B)(6) 2021 A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX DISCREPANT RESULT (SUSPECTED FALSE NEGATIVE RESULT) WHEN TESTING PATIENT SAMPLES WITH VIDAS® SARS-COV-2 IGG (9COG) 60T (REF. 423834, LOT 1008630790, AND EXPIRY DATE 23-FEB-2022) COMPARED TO ANOTHER METHOD (ROCHE). THE CUSTOMER OBTAINED THE FOLLOWING RESULTS: SAMPLE 1: (B)(6): VIDAS SARS COV-2 IGG: -0.02 TV NEGATIVE VIDAS SARS COV-2 IGM: 1.08 TV POSITIVE OTHER METHOD (VIRCLIA ?): IGA/IGM POSITIVE AND IGG IS DOUBTFUL (WITHIN THE GREY ZONE) THE DISCREPANCY IS ON VIDAS SARS COV-2 IGG FOR VIDAS COVG -0.02 TV (-2 RFV) => THIS RESULT CAN ALSO BE ISSUED IF THERE IS NO SAMPLE DISPENSED IN THE SAMPLE WELL, OR NO SPR LOADED IN THE SPR BLOCK. THE CUSTOMER WAS ASKED TO CHECK IF THEY PERFORMED THE VERIFICATION OF PRESENCE OF SPR AND SAMPLE BEFORE STARTING THE RUN. NO CLARIFICATION HAS BEEN PROVIDED BY THE CUSTOMER AT THIS TIME. SAMPLE 2: (B)(6): VIDAS SARS COV-2 IGG: 0.30 TV NEGATIVE VIDAS SARS COV-2 IGM: 1.10 TV POSITIVE OTHER METHOD (VIRCLIA ?): IGA/IGM POSITIVE AND IGG IS POSITIVE SAMPLE 3: (B)(6): VIDAS SARS COV-2 IGG: 0.18 TV NEGATIVE VIDAS SARS COV-2 IGM: 0.46 TV NEGATIVE OTHER METHOD (ECLIA ROCHE): IGA/IGM/IGG POSITIVE => GLOBAL DETECTION SO IMPOSSIBLE TO CHECK WHICH ANTIBODIES ARE DETECTED. SAMPLE 4: (B)(6): VIDAS SARS COV-2 IGG: 0.32 TV NEGATIVE VIDAS SARS COV-2 IGM: 0.19 TV NEGATIVE OTHER METHOD (ECLIA ROCHE): IGA/IGM/IGG POSITIVE => GLOBAL DETECTION SO IMPOSSIBLE TO CHECK WHICH ANTIBODIES ARE DETECTED. SAMPLE 5: (B)(6): VIDAS SARS COV-2 IGG: 0.22 TV NEGATIVE VIDAS SARS COV-2 IGM: 1.10 TV POSITIVE OTHER METHOD (VIRCLIA ?): IGA/IGM POSITIVE AND IGG IS POSITIVE THE CUSTOMER REPORTED THAT SAMPLES (B)(6) WERE COLLECTED ON THE SAME PATIENT, BUT ON DIFFERENT DATES. FOR THESE SAMPLES, IT CAN BE NOTED THAT THERE IS NO EVOLUTION OF ANTIBODIES EITHER ON VIDAS OR WITH THE OTHER METHOD. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY 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
    879734 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008630790

    Patients

    Seq Age Sex Outcome Treatment
    1