BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11096291 · Received December 30, 2020

    Report

    Report Number
    8020790-2020-00147
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Report Date
    February 10, 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 · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN ITALY REGARDING DISCREPANT RESULTS (POTENTIAL FALSE NEGATIVE RESULT) WITH THE PRODUCT VIDAS® SARS-COV-2 IGG (REF 423834, BATCH 1008326330, EXPIRY DATE 28-JUL-2021) COMPARED TO OTHER METHODS. THE CUSTOMER¿S SAMPLE WAS REQUESTED TO BE RETURNED, BUT IT WAS NOT RECEIVED FOR THE INVESTIGATION. THE ANALYSIS OF THE BATCH HISTORY RECORDS OF VIDAS® SARS COV-2 IGG BATCH 1008326330 / 210728-0 SHOWED NO ANOMALIES DURING THE MANUFACTURING, QUALITY CONTROL, AND PACKAGING PROCESSES. THE CONTROL CHART ANALYSIS OF FOUR (4) POSITIVE INTERNAL SAMPLES SHOWED THE CUSTOMER'S LOT, VIDAS® SARS COV-2 IGG REFERENCE 423834 BATCH 1008326330 / 210728-0, WAS IN THE TREND OF OTHER VIDAS® BATCHES. ALL OF THE SAMPLES WERE IN ACCORDANCE OF THEIR ACCEPTABLE RANGES. THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE VIDAS® SARS COV-2 IGG NEGATIVE RESULT WITH INTERNAL SAMPLES TESTED ON THE RETAIN KIT OF VIDAS® SARS COV-2 IGG REFERENCE 423834 BATCH 1008326330 / 210728-0. THE RESULTS OF THE INTERNAL SAMPLES WERE WITHIN SPECIFICATION RANGES AND WITHOUT ANY OBSERVATION OF INTERPRETATION CHANGE. WITHOUT THE CUSTOMER¿S SAMPLE RETURN BIOMERIEUX CANNOT FURTHER INVESTIGATE THIS ISSUE. ACCORDING TO THE INVESTIGATION, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS® SARS COV-2 IGG REF. 423834 BATCH 1008326330 / 210728-0. IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS® SARS COV-2 IGG ASSAY AT SECTION LIMITATIONS OF THE METHOD: "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." ABBOTT AND ROCHE METHODS DO NOT DETECT THE SAME TARGET (NUCLEOCAPSID) THAN THE VIDAS® METHOD (RBD SUBUNIT OF SPIKE).

    Description of Event or Problem · 1

    ON THE (B)(6) 2020, A CUSTOMER IN ITALY REPORTED TO BIOMÉRIEUX THAT THEY HAVE OBTAINED DISCREPANT RESULTS (POTENTIAL FALSE NEGATIVE RESULT) WITH THE PRODUCT VIDAS® SARS-COV-2 IGG (REF 423834, BATCH 1008326330, EXPIRY DATE 28-JUL-2021) COMPARED TO OTHER METHODS. THE CUSTOMER STATED THAT A PATIENT SAMPLE WAS REPEATEDLY POSITIVE (THREE TIMES) ON SWAB, EVEN AFTER HAVING SPENT 14 DAYS OF QUARANTINE, HE WAS NEGATIVE ONLY TO THE 4TH TEST (ON SWAB) THAT HAS BEEN PRACTICED. THE RESULTS WERE AS FOLLOWS: ABBOTT: IGG RESULT 1 = 2.10 ; IGG RESULT 2 = 1.10 : POSITIVE INTERPRETATION ROCHE: IG RESULT = 2.18 : POSITIVE INTERPRETATION. VIDAS: IGG RESULT 1 = 0.67 ; IGG RESULT 2 = 0.87 ; IGG RESULT 3 = 0.70 : NEGATIVE INTERPRETATION 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
    1560575 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008326330

    Patients

    Seq Age Sex Outcome Treatment
    1