BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 10726124 · Received October 23, 2020

    Report

    Report Number
    8020790-2020-00114
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Report Date
    December 2, 2020
    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 ITALY REGARDING OBTAINING POTENTIAL FALSE POSITIVE RESULTS FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® SARS-COV-2 IGG (9COG) 60T (REF 423834, LOT 1008204630). THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY WHERE IT WAS TESTED WITH THE ABBOTT METHOD AND OBTAINED NEGATIVE RESULTS. AN ANALYSIS OF THE BATCH HISTORY RECORD OF VIDAS® SARS COV-2 IGG LOT 1008204630 / 210716-0 SHOWED NO ANOMALIES DURING THE MANUFACTURING, QUALITY CONTROL, AND PACKAGING PROCESSES. NO NON-CONFORMITY NOR CAPA LINKED TO THE CUSTOMER'S COMPLAINT RECORDED ON THE SUBJECT LOT. THE COMPLAINTS LABORATORY PERFORMED SEVERAL TESTS. THE CUSTOMER¿S SAMPLE WAS NOT AVAILABLE, HOWEVER, BIOMERIEUX CONDUCTED TESTING USING INTERNAL SAMPLES. THE STUDY OF INTERNAL SAMPLES CONTROL CHARTS WAS CARRIED OUT ON FOUR (4) INTERNAL SERA USING 17 BATCHES INCLUDING THE BATCH MENTIONED BY THE CUSTOMER, VIDAS® SARS COV-2 IGG LOT 1008204630 / 210716-0. ALL VALUES WERE WITHIN SPECIFICATIONS. THE CUSTOMER'S LOT WAS IN THE TREND OF THE OTHER LOTS. THE COMPLAINTS LABORATORY TESTED FOUR (4) INTERNAL SAMPLES (TWO WITH NEGATIVE TARGETS AND TWO POSITIVE TARGETS) ON THE RETAIN KIT VIDAS® SARS COV-2 IGG LOT 1008204630 / 210716-0. ALL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBSERVED BEFORE THE BATCH WAS RELEASED. THE LAB DID NOT OBSERVE ANY EVOLUTION OVER TIME ON VIDAS® SARS COV-2 IGG LOT 1008204630 / 210716-0. THE COMPLAINTS LABORATORY TESTED 10 SAMPLES COLLECTED BEFORE THE PANDEMIC (SO EXPECTED NEGATIVE) ON VIDAS® SARS COV-2 IGG LOT 1008204630 / 210716-0. ALL OF THE TESTS GAVE A NEGATIVE RESULT WITH INDEXES BETWEEN 0.07 AND 0.31 TV (FAR FROM THE POSITIVE CUT-OFF OF 1.00 TV). NO FALSE POSITIVE RESULTS OBSERVED. IN CONCLUSION, THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE CUSTOMER'S ANOMALY DURING THE INVESTIGATION PERFORMED NEITHER ON OUR INTERNAL QUALITY CONTROL MATERIAL, NOR ON NATURAL SAMPLES COLLECTED BEFORE THE PANDEMIC. WITHOUT THE CUSTOMER'S RETURN SAMPLE, BIOMERIEUX CANNOT PURSUE FURTHER INVESTIGATION AND CONFIRM WHICH RESULT SHOULD BE EXPECTED. ACCORDING TO THE COMPLAINT TREND ANALYSIS PERFORMED, THERE IS ONLY THIS COMPLAINT REGISTERED FOR DISCREPANCY ISSUE ON VIDAS SARS COV-2 IGG LOT 1008204630/210716-0 SO NO RECURRENCE OF SUCH ISSUE. PLEASE NOTE: THE FOLLOWING IS MENTIONED IN VIDAS® SARS COV-2 IGM PACKAGE INSERT 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.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING POTENTIAL FALSE POSITIVE RESULTS FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® SARS-COV-2 IGG (9COG) 60T (REF 423834, LOT 1008204630). THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY WHERE IT WAS TESTED WITH THE ABBOTT METHOD AND OBTAINED NEGATIVE RESULTS. VIDAS SARS-COV-2 IGG = 1.66 (POSITIVE). SARS COV IGG ABBOTT = 0.40 AND 0.30 (NEGATIVE). IT WAS REPORTED THAT THE CUSTOMER PERFORMED ADDITIONAL TESTING ON ANOTHER SAMPLE FROM THE PATIENT AND POSITIVE RESULTS WERE OBTAINED AGAIN WITH THE VIDAS, WHILE NEGATIVE RESULTS WERE OBTAINED WITH THE ABBOTT METHOD. 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 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
    1194723 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008204630

    Patients

    Seq Age Sex Outcome Treatment
    1