BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11701667 · Received April 21, 2021

    Report

    Report Number
    8020790-2021-00108
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 A POTENTIAL FALSE NEGATIVE RESULT WHILE TESTING TWO (2) DIFFERENT PATIENT STRAINS FROM SEPARATE PATIENTS USING THE VIDAS ® SARS-COV-2 IGG (9COG) 60T (REFERENCE # 423834, LOT # 1008331100). 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. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: THE ANALYSIS OF THE BATCH HISTORY RECORD OF VIDAS SARS COV-2 IGG LOT 1008331100/210921-0 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. THE CUSTOMER DID NOT HAVE ANY REMAINING SAMPLES TO BE RETURNED FOR INVESTIGATION. THE COMPLAINTS LABORATORY PERFORMED A CONTROL CHART ANALYSIS ON FIVE (5) INTERNAL SAMPLES (TARGETS BETWEEN 0.09 TV AND 11 TV). THE SAMPLES WERE TESTED ON SEVEN (7) BATCHES OF VIDAS SARS COV-2 IGG INCLUDING THE LOT MENTIONED BY CUSTOMER. THE ANALYSIS SHOWED THAT THE SAMPLES COMPLY WITH THE EXPECTATIONS AND VIDAS SARS COV-2 IGG BATCH 1008331100/210921-0 IS IN THE TREND COMPARED TO THE OTHER LOTS. THE COMPLAINTS LABORATORY PERFORMED A TEST ON THREE (3) INTERNAL SAMPLE: TWO (2) POSITIVE SAMPLES (TARGETS 1.75 AND 1.54 TV) AND ONE (1) NEGATIVE SAMPLE (TARGET : 0.65 TV) ON THE RETAIN KIT VIDAS SARS COV-2 IGG LOT 1008331100/210921-0. ALL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBSERVED BEFORE THE BATCH RELEASE. NO EVOLUTION WAS OBSERVED OVER TIME OF VIDAS SARS COV-2 IGG BATCH 1008331100/210921-0. THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE VIDAS SARS COV-2 IGG NEGATIVE RESULT OBSERVED BY THE CUSTOMER WHEN TESTING INTERNAL POSITIVE SAMPLES ON THE BATCH 1008331100/210921-0. WITHOUT ANY CONCERNED SAMPLE AVAILABLE, IT WAS NOT POSSIBLE TO PURSUE FURTHER INVESTIGATION. THEREFORE, A ROOT CAUSE WAS NOT DETERMINED. AS THE (B)(6) VACCINE INDUCED NEUTRALIZING ANTIBODIES AGAINST SPIKE PROTEIN AND NUCLEOCAPSID ANTIGEN, A HYPOTHESIS COULD BE THAN THESE TWO PATIENTS HAVE NOT DEVELOPED ENOUGH ANTIBODIES DIRECTED AGAINST SPIKE PROTEIN AT THE TIME OF THE TEST AS VIDAS SARS COV-2 IGG IS RECOGNIZING THE SPIKE PROTEIN. IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS SARS COV-2 IGG REF.423834 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. ACCORDING TO THE DATA ABOVE, VIDAS SARS COV-2 IGG REF 423834 LOT 1008331100/210921-0 IS WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A POTENTIAL FALSE NEGATIVE RESULT WHILE TESTING TWO (2) DIFFERENT PATIENT STRAINS FROM SEPARATE PATIENTS USING THE VIDAS ® SARS-COV-2 IGG (9COG) 60T (REFERENCE # 423834, LOT # 1008331100). BOTH PATIENTS WERE VACCINATED WITH (B)(6) VACCINE (B)(6) AND RECEIVED THEIR SECOND DOSE APPROXIMATELY A MONTH AGO. INTERPRETATION OF RESULTS: INTERPRETATION OF THE INDEX (I) IS AS FOLLOWS: INDEX INTERPRETATION I < 1.00 NEGATIVE I >= 1.00 POSITIVE VIDAS ® SARS-COV-2 IGG RESULTS: 0.57, NEGATIVE 0.27, NEGATIVE THE CUSTOMER SENT THE SAMPLES TO AN EXTERNAL LAB THAT TESTED THE SAMPLES USING ABBOTT SARS-COV-2 IGG II QUANT AND THE RESULTS WERE POSITIVE FOR BOTH PATIENTS. BIOMERIEUX VISTED THE CUSTOMER SITE TO REVIEW CALIBRATION AND INVESTIGATE THE RESULTS. THE SAMPLES WERE ALSO ANALYZED A SECOND TIME USING AN ABBOTT AND THE RESULTS WERE 69.0 AND 68.3 AU/ML RESPECTIVELY. THE ABBOTT SARS-COV-2 IGG II QUANT CUTOFF IS 50.0 AU/ML AS STATED IN THE INSERT. THE CUSTOMER HAS NOT PERFORMED A QCV. THE VIDAS TESTING WAS PERFORMED AS A DEMONSTRATION FOR A PROSPECTIVE VIDAS USER; THEREFORE, THERE WERE NO PATIENT RESULTS AFFECTED, NO WRONG RESULT REPORTED TO A PHYSICIAN, NO PATIENTS WERE HARMED OR TREATED INCORRECTLY AND NO DELAYED RESULT CLAIMED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE 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
    598646 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008331100

    Patients

    Seq Age Sex Outcome Treatment
    1