VIDAS LYME IGM

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF UNDERESTIMATED RESULTS IN ASSOCIATION WITH THE VIDAS® LYME IGM TEST KIT (REF. 30319 - LOT 1008136160.) THE QUALITY CONTROL SAMPLE WAS ACCURUN 132 (LOT 1048348). SINCE MID-DECEMBER IN TOTAL THIS QC SAMPLE WAS TESTED 20 TIMES ON THE SAME BATCH OF VIDAS LYME IGM REF. 30319. GLOBAL AVERAGE AT 0.427 AND SD OF 0.0511 OR CV OF 12%. ONE SINGLE BATCH WAS USED AND CALIBRATIONS WERE PERFORMED ON (B)(6) 2020, ON (B)(6) 2021 AND ON (B)(6) 2021. FROM (B)(6) 2020 TO (B)(6) 2021 THE QC SAMPLE TEST RESULTS WERE FROM 0.43 TO 0.50. IT WAS REPORTED THAT FROM (B)(6) 2021 THE VALUES WERE LOWER FROM 0.32 TO 0.38. FOLLOWING THE EXPORT OF THE CALIBRATION RESULTS PROVIDED BY THE CUSTOMER, CALIBRATIONS WERE PERFORMED ON (B)(6) 2020, ON (B)(6) 2021 AND ON (B)(6) 2021. IT WAS UNCLEAR IF CALIBRATION PERFORMED ON (B)(6) 2020 WAS COMPLETE OR NOT. IT WAS ALSO INDICATED THAT FOR THE PATIENTS, THERE WAS A DELAY GREATER THAN 24 HOURS IN REPORTING RESULTS. THERE IS NO INDICATION THAT THIS DELAY LEAD TO ANY ADVERSE IMPACT TO PATIENTS. THE CUSTOMER HAS BEEN ABLE TO SUCCESSFULLY COMPLETE A CALIBRATION USING A NEW LOT (1008391150). ON (B)(6) 2021, THE ACCURUN 132 QUALITY CONTROL RESULT WAS 0.58 WHICH IS CLOSER TO THE RESULTS OBTAINED FROM (B)(6) 2020 TO (B)(6) 2021. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL SAMPLE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN FRANCE REGARDING UNDERESTIMATED RESULTS IN ASSOCIATION WITH THE VIDAS® LYME IGM TEST KIT (REF. 30319 - LOT 1008136160). THE QUALITY CONTROL SAMPLE WAS ACCURUN 132 (LOT 1048348). A REVIEW OF THE QUALITY DATA SHOWED NO ANOMALIES DURING THE STAGES OF MANUFACTURE, QUALITY CONTROL OR PACKAGING FOR VIDAS® LYME IGM TEST KIT LOT 1008136160. THE CUSTOMER RETURNED ONE (1) SET OF VIDAS® LYME LOT 1008136160/210605, AND ONE (1) QUALITY CONTROL SAMPLE OF SERA CARE ACCURUN 132 BORRELIA BURGDORFERI IGM LOT 10448348 TO BIOMÉRIEUX FOR INVESTIGATION. THE COMPLAINTS LABORATORY TESTED THREE (3) INTERNAL SAMPLES ON THE RETAIN KIT OF VIDAS® LYME IGM LOT 1008136160 / 210605-0. ALL SAMPLE RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS. THERE WAS NO DRIFT IN LOT 1008136160 / 210605-0 SINCE THE BATCH WAS RELEASED. THE COMPLAINTS LABORATORY PERFORMED A REPEATABILITY TEST WITH AN INTERNAL SAMPLE (TARGET 1.57 TV) FIVE (5) TIMES ON RETAIN KIT VIDAS® LYME IGM LOT 1008136160 / 210605-0, AND FIVE (5) TIMES ON THE CUSTOMER'S RETURNED KIT RETURNED (SAME LOT). ALL RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATION AND SIMILAR BETWEEN THE RETAIN KIT AND THE CUSTOMER'S KIT. THE ACCURUN 132 SAMPLE RETURNED BY THE CUSTOMER AND AN INTERNAL SAMPLE (TARGET 1.57 TV) WERE TESTED ON RETAIN KIT VIDAS® LYME LOT 1008136160 / 210605-0, AND ON ANOTHER LOT (1008490740 / 211221- 0) WITH OTHER RAW MATERIAL. THE COMPLAINTS LABORATORY CONFIRMED A LOWER RESULT WITH THE RETAIN KIT COMPARED TO VIDAS® LYME 211221-0 ON THE ACCURUN SAMPLE, BUT WITHOUT CHANGE OF INTERPRETATION. THE ROOT CAUSE OF THIS COMPLAINT HAS NOT BEEN IDENTIFIED. ACCORDING TO THE INVESTIGATION, NO ANOMALIES WERE HIGHLIGHTED WITH THE QUALITY DATA ANALYSIS OR THE TESTS PERFORMED. VIDAS® LYME IGM LOT 1008136160 / 210605-0 IS STILL WITHIN EXPECTED PERFORMANCE. SEE SECTION H10.