BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGM

    MDR report key: 10712172 · Received October 21, 2020

    Report

    Report Number
    8020790-2020-00111
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Report Date
    January 21, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 POSITIVE RESULTS FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® SARS-COV-2 IGM (9COM) 60T (REF 423833, LOT 1008206950). A CONTROL CHART ANALYSIS PERFORMED ON FOUR (4) INTERNAL SAMPLES FOR SEVEN (7) VIDAS SARS COV-2 IGM BATCHES, INCLUDING THE CUSTOMER BATCH, 1008206950 / 210715-0 WAS DONE. ALL THE RESULTS WERE COMPLIANT TO THE SPECIFICATIONS AND VIDAS® SARS COV-2 IGM BATCH 1008206950 / 210715-0 WAS IN THE TREND OF THE OTHER LOTS. THE COMPLAINTS LABORATORY REPRODUCED THE POSITIVE RESULT OBSERVED BY THE CUSTOMER WHEN TESTING THE PATIENT'S SAMPLE ON VIDAS® SARS COV-2 IGM LOT 1007090850 / 210509-0 (MANUFACTURED WITH DIFFERENT RAW MATERIAL THAN THE LOT USED BY THE CUSTOMER). THIS SHOWS THE POSITIVE RESULT IS NOT LINKED TO A SPECIFIC BATCH OF VIDAS® SARS COV-2 IGM REF. 423833. THE LAB DID NOT REPRODUCE THE VIDAS® SARS COV-2 IGM POSITIVE RESULT WHEN TESTING NATURAL SAMPLES COLLECTED BEFORE THE PANDEMIC WITH THE RETAIN KIT OF THE CUSTOMER¿S LOT. ALL OF THE SAMPLES GAVE A NEGATIVE INTERPRETATION. THE VIDAS® SARS COV-2 IGM POSITIVE RESULT CAN BE DUE TO THE PRESENCE IN THIS SAMPLE OF AN INTERFERENCE SUCH AS, BUT NOT LIMITED TO, ANTI-NUCLEAR ANTIBODY OR ANTI HAMA. UNFORTUNATELY THE REMAINING VOLUME OF THE PATIENT SAMPLE WAS TOO LOW TO HIGHLIGHT THE ROOT CAUSE OF THIS ISSUE, WHICH IS NOT LINKED TO THE PRESENCE OF RHEUMATOID FACTOR. THE PACKAGE INSERT OF VIDAS® SARS COV-2 IGM REF. 423833 STATES THE FOLLOWING IN THE "LIMITATIONS OF THE METHOD" SECTION: - ¿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. - ¿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 INVESTIGATION OUTCOMES, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS® SARS COV-2 IGM BATCH 1008206950 / 210715-0.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR A PATIENT SAMPLE WHEN IN ASSOCIATION WITH THE VIDAS® SARS-COV-2 IGM (9COM) 60T (REF 423833, LOT 1008206950). SAMPLE WAS ALSO SENT TO A DIFFERENT LABORATORY FOR CONFIRMATION TESTING WITH AN ALTERNATIVE CHEMILUMINESCENCE METHOD. THE ALTERNATIVE METHOD RESULTS DID NOT CONFIRM THE POSITIVE RESULT OBTAINED BY VIDAS. VIDAS SARS-COV-2 IGM = POSITIVE. ALTERNATIVE CHEMILUMINESCENCE METHOD = NEGATIVE. THE PATIENT IS A TEACHER THAT WAS BEING TESTED FOR SCREENING PURPOSES BEFORE RETURNING TO THE CLASSROOM. THE PATIENT HAD NO CHARACTERISTIC SYMPTOMS OF COVID-19. THE CUSTOMER ALSO REPORTED THAT THE PATIENT HAS NO OTHER RELEVANT PATHOLOGIES. THE POSITIVE RESULTS OBTAINED BY VIDAS WERE NOT REPORTED TO THE TREATING PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT 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
    1174657 VIDAS SARS-COV-2 IGM VIDAS® SARS-COV-2 IGM QKO BIOMERIEUX SA 1008206950

    Patients

    Seq Age Sex Outcome Treatment
    1