VIDAS® LYME IGG

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE UNITED KINGDOM THAT THEY OBTAINED FALSE NEGATIVE RESULT WHEN TESTING AN EQC SAMPLE WITH VIDAS® LYME IGG 60 TEST (REF. 30320, LOT # 1008800180). THE CUSTOMER HAS NOT SENT THE FINAL REPORT FROM LABQUALITY, SO THE RESULTS EXPECTED BY THE SUPPLIER ARE NOT KNOWN. MOREOVER, THE "WORK LIST" SENT BY THE CUSTOMER MENTIONS NEQAS SAMPLES AND NOT LABQUALITY. INVESTIGATION DEVICE HISTORY RECORD ANALYSIS OF THE BATCH HISTORY RECORDS OF VIDAS LYME IGG REF 30320 LOT 1008800180 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. COMPLAINT ANALYSIS AS OF THE DATE OF THIS INVESTIGATION, NO OTHER SIMILAR COMPLAINT HAVE BEEN RECEIVED. THE VIDAS LYME IGG REF 30320 LOT 1008800180, IS PART OF THE FSCA 5333-1, RELATED TO THE SUBSTRATE ERROR, AND THE NEW EXPIRATION DATE WAS 09 JAN 2022. THE CUSTOMER SHOULD NOT HAVE USED THIS LOT, AS IT WAS ALREADY EXPIRED AT THE TIME OF THE CUSTOMER'S TESTING. CONTROL CHART ANALYSIS CONTROL CHART ANALYSIS WAS CARRIED OUT ON 4 INTERNAL SAMPLES (TARGETED BETWEEN 0.73 VT AND 3.71 VT), USING 7 BATCHES INCLUDING THE LOT MENTIONED BY THE CUSTOMER. ALL VALUES ARE WITHIN SPECIFICATIONS, AND RESULTS FROM THE CUSTOMER¿S LOT WERE CONSISTENT WITH THOSE FROM THE OTHER LOTS. TESTS/ANALYSIS PERFORMED PROBIOQUAL (FRENCH EQC SUPPLIER) CAMPAIGN ANALYSIS: THE IU LABORATORY PARTICIPATES IN A FRENCH SUPPLIER (PROBIOQUAL) CAMPAIGN AND HAS RECEIVED THE OVERALL RESULTS FOR THE 2022 CAMPAIGN ON WHICH THE DATA FOR THE PEER GROUP USING THE VIDAS LYME IGG ARE FOR 2 POSITIVE SAMPLES : SAMPLE (B)(6): 10 PARTICIPANTS FOR VIDAS PEER GROUP, ALL HAD A POSITIVE RESULT AS THE ASSIGNED RESULT. ALL METHODS COMBINED, 100% OF THE LABORATORIES MADE A COMPLIANT RESPONSE. SAMPLE (B)(6): 8 PARTICIPANTS FOR VIDAS PEER GROUP, ALL OBTAINED A POSITIVE RESULT AS THE ASSIGNED RESULT. ALL METHODS COMBINED, 100% OF THE LABORATORIES GAVE A POSITIVE RESPONSE. SO FOR THESE 2 POSITIVE SAMPLES WITH VIDAS LYME IGG THE RESULTS ARE COMPLAINTS WITH THE EXPECTED RESULTS AND WITH THE COMPETITOR METHOD. CONCLUSION THE INVESTIGATION DID NOT IDENTIFY ANY OBVIOUS ROOT CAUSE. WITHOUT MORE INFORMATION FROM THE CUSTOMER, FURTHER INVESTIGATION CANNOT BE PURSUED. ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS AND THE ANALYSIS OF QUALITY DATA FOR VIDAS LYME IGG REF 30320 LOT 1008800180. MOREOVER, THERE IS NO SIMILAR COMPLAINT ON THIS BATCH, AND THE RESULTS FROM OTHER EQC SUPPLIER ARE COMPLIANT FOR SIMILAR SAMPLES TESTED BY CUSTOMER. THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF PRODUCT VIDAS LYME IGG REF 30320 LOT 1008800180.

Description of Event or Problem

INTENDED USE THE VIDAS® LYME IGG (LYG) (REF. 30320) ASSAY IS AN AUTOMATED QUALITATIVE TEST INTENDED FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS, FOR THE DETECTION OF IGG ANTIBODIES TO BORRELIA BURGDORFERI SENSU LATO (SL) IN HUMAN SERUM OR PLASMA, TO AID IN THE DIAGNOSIS OF LYME DISEASE. THE VIDAS® LYME IGG (LYGS) (REF. 30320) ASSAY IS AN AUTOMATED QUALITATIVE TEST INTENDED FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS, FOR THE DETECTION OF IGG ANTIBODIES TO BORRELIA BURGDORFERI SENSU LATO (SL) IN CEREBROSPINAL FLUID (CSF), IN ORDER TO DETERMINE INTRATHECAL ANTIBODY PRODUCTION, TO AID IN THE DIAGNOSIS OF NEUROBORRELIOSIS. DESCRIPTION OF THE ISSUE ON (B)(6)2022, A CUSTOMER IN UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULT WHEN TESTING WITH VIDAS® LYME IGG 60 TEST (REF. 30320, LOT # 1008800180, EXPIRY DATE 09-JAN-2022) IN CONTEXT OF EXTERNAL QUALITY CONTROL. THE CUSTOMER WAS TESTED QUALITY CONTROL SAMPLE RELATES TO ROUND 1, 2022, S00 FROM THE COMPANY LABQUAILTY. THE EXPECTED RESULT WAS POSITIVE AND THE CUSTOMER OBTAINED AN INDEX VALUE BELOW 0.20 INDICATING A NEGATIVE RESULT. ALL CONTROLS WERE GOOD. AS IT WAS AN EXTERNAL QUALITY CONTROL SAMPLE, NO PATIENT SAMPLE WAS INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: REFERENCE 30320 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE (B)(4) (VIDAS LYME IGG II).