VIDAS SARS-COV-2 IGM
Report
- Report Number
- 8020790-2021-00141
- Event Type
- Malfunction
- Date Received
- June 24, 2021
- Report Date
- October 27, 2021
- Manufacturer
- BIOMERIEUX SA
- Product Code
- QKO
- PMA / PMN Number
- UNCLASSIFIED
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED NEGATIVE RESULTS ON SEVERAL PATIENTS¿ SAMPLES WHEN TESTING THEM ON VIDAS SARS COV-2 IGM LOTS 1008446600 AND 1008388570. SAMPLES WERE POSITIVE USING A COMPETITOR METHOD (ROCHE ELECSYS, COBAS INSTRUMENT). SAMPLE ID: (B)(6): NEGATIVE WITH VIDAS SARS COV-2 IGG AND VIDAS SARS COV-2 IGM AND COMPETITOR METHOD COBAS ROCHE GAVE A POSITIVE INTERPRETATION (GLOBAL DETECTION OF ANTIBODIES AGAINST SARS COV-2) SAMPLE ID: (B)(6): NEGATIVE WITH VIDAS SARS COV-2 IGG AND VIDAS SARS COV-2 IGM AND COMPETITOR METHOD COBAS ROCHE GAVE A POSITIVE INTERPRETATION (GLOBAL DETECTION OF ANTIBODIES AGAINST SARS COV-2). SAMPLE ID: (B)(6): NEGATIVE WITH VIDAS SARS COV-2 IGG AND VIDAS SARS COV-2 IGM AND COMPETITOR METHOD COBAS ROCHE GAVE A POSITIVE INTERPRETATION (GLOBAL DETECTION OF ANTIBODIES AGAINST SARS COV-2). SAMPLE ID: (B)(6): NEGATIVE WITH VIDAS SARS COV-2 IGG AND VIDAS SARS COV-2 IGM AND COMPETITOR METHOD COBAS ROCHE GAVE A POSITIVE INTERPRETATION (GLOBAL DETECTION OF ANTIBODIES AGAINST SARS COV-2). NO CLINICAL HISTORY AVAILABLE (CONTACT, INFECTION OR VACCINATION). SAMPLE ID: (B)(6): NEGATIVE WITH VIDAS COV-2 IGG AND VIDAS SARS COV-2 IGM AND COMPETITOR METHOD COBAS ROCHE GAVE A POSITIVE INTERPRETATION (GLOBAL DETECTION OF ANTIBODIES AGAINST SARS COV-2). SAMPLE ID: (B)(6): NEGATIVE WITH VIDAS COV-2 IGG AND VIDAS SARS COV-2 IGM AND COMPETITOR METHOD COBAS ROCHE GAVE A POSITIVE INTERPRETATION (GLOBAL DETECTION OF ANTIBODIES AGAINST SARS COV-2). SAMPLE ID: (B)(6): NEGATIVE WITH VIDAS COV-2 IGG AND VIDAS SARS COV-2 IGM AND COMPETITOR METHOD COBAS ROCHE GAVE A POSITIVE INTERPRETATION (GLOBAL DETECTION OF ANTIBODIES AGAINST SARS COV-2). SIX SAMPLES WERE SENT BACK BY THE CUSTOMER (4 SAMPLES CORRESPONDING TO THE COMPLAINT CASE (B)(4) NAMELY SAMPLES ID (B)(6), ID (B)(6), ID (B)(6) AND ID (B)(6) AND 2 OTHER SAMPLES ID (B)(6) AND (B)(6) CORRESPONDING TO CASE (B)(4). REVIEW OF PREVIOUS COMPLAINT RECORDS. BIOMÉRIEUX RECORDED ONE (1) COMPLAINT ON VIDAS SARS COV-2 IGM LOT 1008446600 AND ONE (1) COMPLAINT ON VIDAS SARS COV-2 IGM LOT 1008388570/211029-0 FOR SUSPECTED FALSE NEGATIVE RESULT. THE INVESTIGATOR THEN LOOKED AT THE QUALITY CONTROL RECORDS FOR THE CUSTOMER'S LOTS. THERE ARE NEITHER CAPAS NOR NON-CONFORMITIES RECORDED ON THIS VIDAS ASSAY IN LINK WITH THE OBJECT OF THESE COMPLAINTS. ACCORDING TO QUALITY CONTROL RECORD, THERE IS NO ANOMALY HIGHLIGHTED DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES OF VIDAS SARS COV-2 IGM LOTS 1008446600 AND 1008388570. CONTROL CHART ANALYSIS WAS CARRIED OUT FOR FOUR INTERNAL SAMPLES WITH (1 WITH A NEGATIVE TARGET AND 3 WITH A POSITIVE TARGET), USING SEVEN (7) BATCHES OF VIDAS SARS COV-2 IGM INCLUDING THE CUSTOMERS¿ LOTS. ALL THE SAMPLES RESULTS COMPLY WITH THE SPECIFICATIONS AND BOTH LOTS OF VIDAS SARS COV-2 IGM ARE CONSISTENT COMPARED TO THE OTHER LOTS. TESTING VIDAS SARS COV-2 IGM: THREE (3) INTERNAL SAMPLES WITH A POSITIVE TARGET WERE TESTED ON THE TWO (2) LOTS OF VIDAS SARS COV-2 IGM MENTIONED BY THE CUSTOMER. ALL THE SAMPLES GAVE A POSITIVE RESULT AS EXPECTED WITH NO SIGNIFICANT DIFFERENCE COMPARED TO THE RESULTS OBSERVED BEFORE THE BATCHES RELEASE. BIOMÉRIEUX DID NOT OBSERVE ANY EVOLUTION OVER TIME OF THE RESULTS FOR VIDAS SARS COV-2 IGM ASSAY FOR BOTH LOTS USED BY THE CUSTOMER (B)(6). EXTERNAL LABORATORY RESULTS: ALL THE PATIENTS¿ SAMPLES WERE SENT TO AN EXTERNAL LABORATORY (BIOMNIS EUROFINS) FOR ADDITIONAL TESTING USING THE TEST NOVALISA SARS COV-2 IGM NOVATEC. ALL THE SAMPLES GAVE A NEGATIVE RESULT FOR IGM ANTI SARS COV-2 WITH AN INDEX FAR FROM THE POSITIVE THRESHOLD. CHARACTERIZATION DEPARTMENT TESTING: ID# (B)(4) AND ID# (B)(4) WERE ALSO TESTED WITH AN IN-HOUSE WESTERN BLOT. USING THE SAME MAIN RAW MATERIALS AS THOSE USED IN THE MANUFACTURING OF VIDAS SARS COV-2 IGM ASSAY (RBD ANTIGEN AND CONJUGATE). USING A NUCLEOCAPSID ANTIGEN AND AN EXTERNAL RBD PROTEIN. THE REVELATION WAS PERFORMED USING HUMAN IMMUNOGLOBULINS IGM AND IGG. WE DO NOT OBSERVE ANY IMMUNE REACTIVITY AGAINST NUCLEOCAPSID WITH THE IGM CONJUGATE FOR BOTH SAMPLES. FOR THE SAMPLE ID (B)(6), A WEAK BAND WAS OBSERVED FOR RBD BUT THE IMMUNE REACTIVITY WAS LOWER THAN THE ONE OBSERVED FOR AN INTERNAL SARS COV-2 IGM SAMPLE WITH AN INDEX BELOW THE POSITIVE THRESHOLD OF THE VIDAS METHOD. VIDAS SARS COV-2 IGM PACKAGE INSERT CONTAINS THE FOLLOWING INFORMATION IN THE LIMITATIONS OF THE METHOD SECTION: "RESULTS OBTAINED USING SAMPLES FROM SARS-COV-2 INFECTED PATIENTS MUST BE INTERPRETED WITH CAUTION. THIS ASSAY IS INTENDED FOR QUALITATIVE DETECTION ONLY. TEST VALUE ITSELF CANNOT BE USED TO DETERMINE THE QUANTITY OF SARS COV 2 IGM ANTIBODIES. THE MAGNITUDE OF THE MEASURED RESULT ABOVE THE THRESHOLD IS NOT INDICATIVE OF THE TOTAL AMOUNT OF ANTIBODY PRESENT IN THE SAMPLE. 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." CONCLUSION: BIOMERIEUX DID NOT REPRODUCE THE CUSTOMER¿S ISSUE (NAMELY A NEGATIVE INTERPRETATION) WHEN TESTING POSITIVE INTERNAL SAMPLES ON BOTH LOTS OF VIDAS SARS COV-2 IGM MENTIONED BY THE CUSTOMER (B)(6). THE SAMPLES SUBMITTED BY THE CUSTOMER GAVE A NEGATIVE INTERPRETATION WITH AN INDEX FAR FROM THE POSITIVE THRESHOLD WHEN TESTING IN AN EXTERNAL LABORATORY USING THE METHOD NOVALISA SARS COV-2 IGM NOVATEC. SAMPLE ID (B)(6) AND ID (B)(6) SHOWED NO DETECTABLE IGM ANTIBODIES AGAINST NUCLEOCAPSID AND THE SAMPLE ID (B)(6) A VERY WEAK IGM REACTIVITY AGAINST RBD PROTEIN. ACCORDING TO THE INVESTIGATIONS OUTCOMES, THE DISCREPANT RESULTS BETWEEN METHODS COULD BE LINKED TO THE SAMPLES PROFILE AND THE FORMAT OF THE METHOD (SEPARATE IGM DETECTION VERSUS GLOBAL DETECTION). SARS COV-2 ANTIBODIES METHODS HAVE DIFFERENT FORMAT (GLOBAL DETECTION OF HUMAN IMMUNOGLOBULINS OR SEPARATE DETECTION; DETECTION OF ANTIBODIES AGAINST NUCLEOCAPSID PROTEIN, SPIKE PROTEIN OR RBD ANTIGEN).
ON (B)(6) 2021, A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX THAT HE OBTAINED A POTENTIAL FALSE NEGATIVE RESULT WHEN TESTING DIFFERENT PATIENT SAMPLES WITH VIDAS SARS-COV-2 IGM (9COM) 60T REF: 423833, (SERIAL NUMBER: (B)(4), EXPIRY DATE: 01-DEC-2021) THERE IS A DISCREPANT RESULT OBSERVED FOR DIFFERENT PATIENTS BETWEEN VIDAS SARS COV-2 ASSAYS AND ROCHE ANTI SARS COV-2 S (ANTI IGA, ANTI IGM AND ANTI IGG). THE CUSTOMER OBTAINED THE FOLLOWING RESULTS: -SAMPLE ID (B)(6) TESTED ON (B)(6) 2021: VIDAS SARS-COV-2 IGM (9COM) 60T : 0.14 TV (NEGATIVE INTERPRETATION). -SAMPLE ID (B)(6) TESTED ON (B)(6) 2021 VIDAS SARS-COV-2 IGM (9COM) 60T : 0.31 TV (NEGATIVE INTERPRETATION). -SAMPLE ID (B)(6) TESTED ON (B)(6) 2021 VIDAS SARS-COV-2 IGM (9COM) 60T : 0.78 TV (NEGATIVE INTERPRETATION). -SAMPLE ID (B)(6) TESTED ON (B)(6) 2021 VIDAS SARS-COV-2 IGM (9COM) 60T : 0.39 TV (NEGATIVE INTERPRETATION. WITH THE OTHER METHOD (ECLIA ROCHE : GLOBAL DETECTION OF ANTI IGA, ANTI IGM AND ANTI IGG): THE RESULTS WERE POSITIVE FOR ALL PATIENT SAMPLES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE NEGATIVE RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: REFERENCE 423833 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, 423833-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423833.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 955139 | VIDAS SARS-COV-2 IGM | VIDAS® SARS-COV-2 IGM | QKO | BIOMERIEUX SA | 1008446600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |