BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 10857569 · Received November 17, 2020

    Report

    Report Number
    8020790-2020-00119
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Report Date
    April 15, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN AUSTRIA REGARDING POTENTIAL FALSE NEGATIVE RESULTS WHEN TESTING SAMPLES FROM TWO (2) SEPARATE PATIENTS WITH VIDAS SARS-COV-2 IGG (9COG) 60T REF. 423834 LOT 1008326330 IN COMPARISON WITH OTHER METHODS. NO ANOMALIES WERE OBSERVED IN THE QUALITY DATA OF VIDAS® SARS-COV-2 IGG REF. 423834 LOT 1008326330 / 210728-0 DURING MANUFACTURING, CONTROL, AND PACKAGING PROCESSES IN LINK WITH THE OBJECT OF THIS COMPLAINT. THE COMPLAINT LABORATORY TESTED FOUR (4) INTERNAL SAMPLES (3 POSITIVE SAMPLES AND 1 NEGATIVE SAMPLE) ON THE RETAIN KIT OF VIDAS® SARS-COV-2 IGG REF. 423834 CUSTOMER'S LOT 1008326330 / 210728-0. THE SAMPLE RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS AND INTERPRETATION. THE COMPLAINT LABORATORY RECEIVED THE CUSTOMER'S RETURN SAMPLE WITHOUT IDENTIFICATION AS TO WHICH PATIENT IT WAS RELATED TO. THE SAMPLE WAS TESTED ON THE RETAIN KIT OF VIDAS® SARS-COV-2 IGG REF. 423834 LOT 1008326330 / 210728-0 (CUSTOMER'S LOT) AND VIDAS® SARS COV IGG LOT 1008366980 / 210928-0 (LOT MANUFACTURED WITH OTHER RAW MATERIALS). THE SAMPLE RESULTS WERE BOTH NEGATIVE FOR THE VIDAS® SARS COV IGG BATCHES. THE CUSTOMER¿S SAMPLE WAS ALSO TESTED ON A COMPETITOR METHOD ¿EUROIMMUN ELISA SARS-COV-2 IGG REF. 2606-9601G ¿. THE DESIGN OF THIS TEST IS BASED ON THE DETECTION OF ANTIBODIES AGAINST SPIKE PROTEIN (S). FOR VIDAS® SARS COV-2 ASSAYS, THE TARGET IS RBD WHICH IS PART OF SPIKE PROTEIN S. THE CUSTOMER'S SAMPLE GAVE AN EQUIVOCAL INTERPRETATION (0.80 <= INDEX <1.1) USING THIS METHOD. TESTING PERFORMED BY THE R&D CHARACTERIZATION DEPARTMENT HIGHLIGHTED THE FOLLOWING: - PRESENCE OF HUMAN ANTIBODIES AGAINST NUCLEOCAPSID WITH A VERY HIGH IMMUNE-REACTIVITY FOR IGG AND A LOWER INTENSITY FOR IGA. - PRESENCE OF HUMAN IGG ANTIBODIES AGAINST RBD IGG WITH AN IMMUNE-REACTIVITY COMPARABLE TO AN INTERNAL SAMPLE WITH A TARGET AT 0.97 TV FOR VIDAS® SARS COV-2 IGG. IN CONCLUSION, THE CUSTOMER¿S NEGATIVE RESULT WAS REPRODUCED. THE RESULTS OBSERVED BY THE CUSTOMER COULD BE DUE TO THE SAMPLE PROFILE ITSELF WITH MAINLY PRESENCE IGG ANTIBODIES AGAINST NUCLEOCAPSID AND A LOWER LEVEL OF ANTIBODIES AGAINST RBD PROBABLY CLOSE TO THE THRESHOLD OF VIDAS SARS COV-2 IGG. THE VIDAS® SARS COV-2 IGG PACKAGE INSERT REF. 423834, AT LIMITATIONS OF THE TEST, STATES THE FOLLOWING INFORMATION: - ¿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 IGG REF. 423834 BATCH 1008326330 / 210728-0 TO ITS EXPECTATIONS. SEE SECTION H10.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) COMPLAINED AFTER HE OBTAINED POTENTIAL FALSE NEGATIVE RESULTS WHEN TESTING SAMPLES FROM TWO (2) SEPARATE PATIENTS WITH VIDAS SARS-COV-2 IGG (9COG) 60T REF. 423834 AND VIDAS SARS-COV-2 IGM (9COM) 60T REF. 423833. THIS MDR IS FOR VIDAS SARS-COV-2 IGG (9COG) 60T REF. 423834 (LOT# 1008326330), PATIENT 1. FOR PATIENT 1 (PATIENT P) : POSITIVE RESULTS WERE OBTAINED WITH ANTIBODY TEST FROM ROCHE (ELECSYS) AND DIASORIN (LIAISON). ADDITIONALLY, THERE WAS A POSITIVE NEUTRALIZATION TEST FROM VIROLOGY, (B)(6). THIS PATIENT HAD A POSITIVE PCR TEST IN THE MEDICAL HISTORY. IT WAS INDICATED THAT THE NEGATIVE RESULTS WERE REPORTED TO THE CLINICIANS. HOWEVER, 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 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
    1314908 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008326330

    Patients

    Seq Age Sex Outcome Treatment
    1