BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11022225 · Received December 16, 2020

    Report

    Report Number
    8020790-2020-00137
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    April 16, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN SPAIN REGARDING A POTENTIAL FALSE NEGATIVE RESULT FOR ONE PATIENT WHILE USING THE VIDAS® 2 SARS-COV-2 IGG (9COG) 60T (REF. 423834, LOT 1008117730). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: THE BATCH WAS CONFIRMED AS 1008117730 / 210528-0. ACCORDING TO THE ANALYSIS OF THE QUALITY DATA, NO ANOMALY WAS OBSERVED DURING THE STAGES OF MANUFACTURE, CONTROL AND PACKAGING. ANALYSIS WAS PERFORMED OF SEVERAL POSITIVE SERA FROM INTERNAL SERUM LIBRARIES ON SEVEN (7) LOTS OF VIDAS SARS COV IGG, INCLUDING THAT OF THE CUSTOMER 210528-0. THE CUSTOMER'S LOT (LOT 210528-0) WAS IN LINE WITH OTHER LOTS. THE FOLLOWING TESTS WERE PERFORMED AT THE INVESTIGATION UNIT LABORATORY: THREE (3) POSITIVE SAMPLES AND ONE (1) NEGATIVE SARS COV IGG WERE TESTED ON THE RETAIN KIT OF SARS COV 2 IGG KIT (LOT 210528-0). THE RESULTS OF THE CALIBRATION COMPLY WITH THE MLE DATA OF THE BATCH. THE RESULTS WERE COMPLIANT FOR NEGATIVE / POSITIVE SERA AND THERE WAS NO DRIFT OF SARS COV IGG (LOT 210528-0). THE SAME TEST WAS PERFORMED ON THE RETURNED PATIENT SAMPLE. C1 VT = 3.77 STANDARDS (2.08 - 5.48). C2 VT = -0.04 STANDARDS <= 0.99. PATIENT SAMPLE 1: VT = 0.01 NEGATIVE. THE SAME SERUM WAS TESTED IN PARALLEL ON ANOTHER BATCH OF VIDAS SARS COV IGG (LOT 210728-0). S1 111/108 RFV STANDARDS 93-203RFV. C1 VT = 2.67 STANDARDS (1.56 - 4.10). C2 VT = -0.03 STANDARDS <= 0.99. PATIENT SAMPLE 1: VT = 0.11 NEGATIVE. THE PATIENT SAMPLE WAS TESTED AT VT = 0.00 AT THE CUSTOMER SITE, AND TESTED AT 0.01 ON THE SAME LOT AND 0.11 ON ANOTHER LOT. THEREFORE, THE CUSTOMER'S NEGATIVE RESULTS WERE CONFIRMED. THE RETURNED PATIENT SAMPLE WAS ALSO TESTED ON A COMPETING KIT (EUROIMMUN), ALSO BASED ON THE DETECTION OF ANTI SPIKE ANTIBODIES. IT WAS CONFIRMED NEGATIVE. A WESTERN BLOT TEST WAS PERFORMED WHICH DEMONSTRATES A SIGNIFICANT PRESENCE OF ANTI-NUCLEOCAPSID HUMAN IGG AND A WEAK PRESENCE OF HUMAN IGG AND ANTI RBD IGA. IN CONCLUSION, THE CUSTOMER ANOMALY WAS REPRODUCED IN THE COMPLAINTS LABORATORY BY TESTING THE PATIENT RETURN SERUM. THE PROBABLE HYPOTHESIS IS THAT THE PATIENT HAS ANTI-NUCLEOCAPSID IGG AND IGA. THE ANTI RBD IMMUNOREACTIVITY BEING VERY WEAK COULD EXPLAIN THE NEGATIVE RESULTS IN VIDAS AND CONFIRMED IN EUROIMMUN, UNLIKE THE POSITIVE RESULTS IN ROCHE ELECSYS (FORMAT WITH NUCLEOCAPSID). IT IS MENTIONED IN VIDAS SARS COV-2 IGG PACKAGE INSERT REF. 423834, AT LIMITATIONS OF THE TEST, 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, VIDAS SARS COV-2 IGG REF. 423834 LOT 1008117730 / 210528-0 IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF OBTAINING A POTENTIAL FALSE NEGATIVE RESULT FOR ONE PATIENT WHILE USING THE VIDAS¿ 2 SARS-COV-2 IGG (9COG) 60T (REF.#: 423834, LOT UNKNOWN). THE CUSTOMER OBTAINED THE FOLLOWING RESULTS FOR THIS PATIENT: SAMPLE 1: WITH VIDAS SARS-COV-2 IGG (9COG) 60T, LOT#: 1008117730 ON (B)(6) 2020: RESULT = 0.00 (NEGATIVE); WITH ROCHE TOTAL ANTIBODY TECHNIC (COBAS) ON 21-OCT-2020: RESULT = 94.27 (POSITIVE). SAMPLE 2: - WITH VIDAS SARS-COV-2 IGG (9COG) 60T, LOT#: 1008117730 ON (B)(6) 2020: RESULT = - 0.01 (NEGATIVE).- WITH ROCHE TOTAL ANTIBODY TECHNIC (COBAS) ON (B)(6) 2020: RESULT = 137.9 (POSITIVE). THIS SECOND SAMPLE WAS SENT TO A REFERENCE LABORATORY SHOWING AN INDEX FOR IGG > 10 (POSITIVE). THE CUSTOMER NOTED THAT THE NEGATIVE RESULTS WERE REPORTED TO THE PHYSICIAN, HOWEVER, THERE WAS NO PATIENT HARM, OR INCORRECT TREATMENT. A BIOM¿RIEUX 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
    1486751 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1