BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGM

    MDR report key: 10545919 · Received September 17, 2020

    Report

    Report Number
    8020790-2020-00086
    Event Type
    Malfunction
    Date Received
    September 17, 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
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE VIDAS SARS-COV-2 IGM (REF. 423833; LOT# 1008114880/210528-0). THE CUSTOMER HAD THREE PATIENT SAMPLES WITH POSITIVE RESULTS UPON INITIAL AND REPEAT TESTING: SAMPLE Nº (B)(6): IGM = 1.05 TV (B)(6) AND IGM = 1.03 TV (B)(6). SAMPLE Nº (B)(6): IGM = 8.31 TV (B)(6) AND IGM = 7.84 TV (B)(6). SAMPLE Nº (B)(6): IGM = 1,75 VT AND 1,68 VT (B)(6). SAMPLES WERE THEN TESTED USING PCR AS WELL AS A SARS IGM TEST FROM ANOTHER MANUFACTURER (ABBOTT), AND ALL THREE PRODUCED NEGATIVE RESULTS. INVESTIGATION: BIOMÉRIEUX CREATED AN INTERNAL INVESTIGATION FOR THIS CUSTOMER ISSUE. FIRST THE INVESTIGATOR REVIEWED THE PRODUCTION HISTORY RECORDS FOR THE LOT IN QUESTION. NO ANOMALIES WERE NOTED DURING THE MANUFACTURING, CONTROL, OR PACKAGING PROCESSES. BIOMÉRIEUX HAS NOT RECEIVED ANY OTHER REPORTS OF THIS NATURE AGAINST THIS LOT OF TESTS. THE INVESTIGATOR ASKED THE CUSTOMER TO SEND IN THE SAMPLES FOR THE INCIDENT. WHEN LOCAL SERVICE COLLECTED THE SAMPLES, THE CUSTOMER SUBMITTED FIVE SAMPLES FOR THE THREE PATIENTS FOR TESTING (VOLUME <0.5ML) - (B)(6). THE COMPLAINT LABORATORY TESTED THE CUSTOMER SAMPLES USING RETAIN SAMPLES OF VIDAS SARS-COV-2 IGM REF. 423833 LOT 1008114880 / 210528-0 (CUSTOMER'S LOT) AND VIDAS SARS-COV -2 IGG REF. 423834 LOT 1008093240 / 210510-0. THE FOLLOWING RESULTS WERE OBTAINED: - (B)(6): VIDAS SARS-COV-2 IGM = 3.37 TV / POSITIVE, VIDAS SARS-COV-2 IGG = 0.02 TV / NEGATIVE. - (B)(6): VIDAS SARS-COV-2 IGM = 7.39 TV / POSITIVE, VIDAS SARS-COV-2 IGG = 0.02 TV / NEGATIVE. - (B)(6): VIDAS SARS-COV-2 IGM = 1.72 TV / POSITIVE, VIDAS SARS-COV-2 IGG = 0.03 TV / NEGATIVE. - (B)(6): VIDAS SARS-COV-2 IGM = 1.01 TV / POSITIVE, VIDAS SARS-COV-2 IGG = 0.02 TV / NEGATIVE. - (B)(6): VIDAS SARS-COV-2 IGM = 2.94 TV / POSITIVE, VIDAS SARS-COV-2 IGG = 0.04 TV / NEGATIVE. THEY REPRODUCED THE CUSTOMER'S POSITIVE RESULTS ON VIDAS SARS-COV-2 IGM LOT 1008114880 / 210528-0. ALL OF THE SAMPLES WERE NEGATIVE USING THE VIDAS SARS-COV-2 IGG TESTS. BIOMÉRIEUX INVESTIGATOR ALSO CONDUCTED SPECIFICITY TESTING USING 30 STORED SAMPLES COLLECTED BEFORE THE PANDEMIC (EXPECTED TO BE NEGATIVE) USING RETAINED SAMPLES FROM THREE LOTS (INCLUDING THE CUSTOMER¿S LOT) OF 1008114880/210528 -0, 1008090880 / 210509-0 AND 1008184830 / 210702-0. FOR THE 10 SAMPLES PERFORMED ON CUSTOMER'S LOT, INDEXES ARE BETWEEN 0.02 AND 0.31 TV. ALL TESTS PRODUCED A NEGATIVE RESULT. ADDITIONALLY, THE INVESTIGATOR SENT THE SAMPLES TO AN EXTERNAL LABORATORY TO BE TESTED USING A COMPETITOR SARS COV-2 IGM METHOD (NOVA-LISA SARS-COV-2 IGM - NOVATEC). ALL SAMPLES GAVE A NEGATIVE IGM INTERPRETATION USING THIS TEST. FINALLY, THE R&D CHARACTERIZATION DEPARTMENT TESTED THE SAMPLES. FOR PATIENT SAMPLE (B)(6), AN IN-HOUSE WESTERN BLOT TESTING WAS PERFORMED (USING THE VIDAS MAIN RAW MATERIAL) LEADING TO AN IGG AND IGM NEGATIVE INTERPRETATION (NO SPECIFIC BAND VISIBLE). NO EVIDENCE OF IMMUNOREACTIVITY AGAINST RBD PROTEIN WAS FOUND WITH SAMPLE (B)(6). FOR THE OTHER FOUR SAMPLES, THERE WAS NOT ENOUGH VOLUME REMAINING FOR ADDITIONAL TESTING. THERE IS NO EVIDENCE OF AN IMMUNOREACTIVITY AGAINST RBD PROTEIN HIGHLIGHTED DURING THE TEST FOR THE SAMPLE (B)(6). CONCLUSION: THE INVESTIGATOR REPRODUCED THE CUSTOMER¿S RESULTS ON VIDAS SARS COV-2 IGM LOT 1008114880 / 210528-0 WHEN TESTING THE PATIENTS' SAMPLES BUT NOT ON NATURAL SAMPLES COLLECTED BEFORE THE PANDEMIC. ALL OF THE PRE-PANDEMIC SAMPLES GAVE A NEGATIVE RESULTS WITH INDEXES WELL UNDER THE POSITIVE THRESHOLD. THE OVERALL ROOT CAUSE HAS NOT BEEN IDENTIFIED, BUT THE INVESTIGATOR WAS ABLE TO SHOW THAT FOR SAMPLE (B)(6), THE REPORTED ISSUE IS NOT LINKED TO THE MAIN RAW MATERIALS (RBD AND CONJUGATE). BIOMÉRIEUX CANNOT INVESTIGATE FURTHER AT THIS TIME, AS THERE WAS NOT ENOUGH MATERIAL LEFT FOR ADDITIONAL TESTING. THE NONSPECIFIC RESULT COULD BE DUE TO INTERFERENCES SUCH AS (BUT NOT LIMITED TO) AUTOIMMUNE DISORDER (ANTINUCLEAR ANTIBODIES) OR RHEUMATOID FACTOR. POSSIBLE CROSS-REACTIVITY IS DESCRIBED IN THE VIDAS SARS COV-2 IGM PACKAGE INSERT (¿CROSS-REACTIVITY¿ SECTION). PACKAGE INSERT ALSO DETAILS (IN ITS OWN SECTION) LIMITATIONS OF THE METHOD, NOTING: ¿ INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S CLINICAL HISTORY AND THE RESULTS OF ANY OTHER TESTS PERFORMED. ¿ RESULTS OBTAINED USING SAMPLES FROM SARS-COV-2 INFECTED PATIENTS MUST BE INTERPRETED WITH CAUTION. ¿ THIS ASSAY IS INTENDED FOR QUALITATIVE DETECTION ONLY. TEST VALUE ITSELF CANNOT BE USED TO DETERMINE THE QUANTITY OF SARS COV 2 IGM ANTIBODIES. ¿ THE MAGNITUDE OF THE MEASURED RESULT ABOVE THE THRESHOLD IS NOT INDICATIVE OF THE TOTAL AMOUNT OF ANTIBODY PRESENT IN THE SAMPLE. ¿ 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. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THE SAME ISSUE ( BAD CORRELATION), WITH VIDAS SARS-COV-2 IGM REF.423833 LOT 1008114880 / 210528-0. ACCORDING TO THE INVESTIGATION ABOVE VIDAS SARS-COV-2 IGM REF. 423833 LOT 1008114880 / 210528-0 IS STILL WITHIN EXPECTED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR THREE PATIENTS WHEN USING VIDAS SARS-COV-2 IGM (9COM) 60T (REF. 423833, LOT 1008114880, EXPIRY DATE = 28-MAY-2021). THE TESTS WERE PERFORMED IN THE CONTEXT OF A SCREENING THAT A COMPANY MADE FOR THEIR WORKERS. THE THREE CONCERNED PATIENTS DISPLAYED NO SYMPTOMS. FOR PATIENT #2, THE CUSTOMER OBTAINED THE FOLLOWING RESULTS WITH VIDAS SARS-COV-2 IGM (9COM) 60T, LOT 1008114880: SAMPLE PATIENT 2: INITIAL TESTING ON (B)(6) 2020: IGM = 8.31 (POSITIVE). REPEAT TESTING ON (B)(6) 2020: IGM = 7.84 (POSITIVE). THE SAMPLE WAS IGG NEGATIVE. PCR TESTING WAS PERFORMED BY THE NATIONAL HEALTH SERVICE, 48 HOURS AFTER THE VIDAS TESTING AND SHOWED NEGATIVE RESULTS. THE ABBOTT TEST WAS USED TO DETECT IGG AND THE SAMPLE WAS NEGATIVE. 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 HAS BEEN INITIATED. NOTE: REFERENCE 423833 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, 423833-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423833.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010150 VIDAS SARS-COV-2 IGM VIDAS® SARS-COV-2 IGM QKO BIOMERIEUX SA 1008114880

    Patients

    Seq Age Sex Outcome Treatment
    1