VIDAS® CMV IGM

Description of Event or Problem

ON (B)(6) 2022, A CUSTOMER FROM (B)(6) NOTIFIED BIOMERIEUX OF A CALIBRATION ISSUE WHICH LED TO DELAYED RESULTS FOR PATIENT SAMPLES USING THE VIDAS CMV IGM 30 TESTS (REF. 30205, LOT 1008873250, EXPIRY DATE = 01JUN2022). THE CUSTOMER MENTIONED A DELAY GREATER THAN 24 HOURS IN REPORTING RESULTS. THE NUMBER OF PATIENTS INVOLVED IS NOT KNOWN AT THIS TIME. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE CALIBRATION ISSUE LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. THE PRODUCT REFERENCE 30205 IS NOT REGISTERED OR SOLD IN THE UNITED STATES. HOWEVER, A SIMILAR DEVICE, REFERENCE 30205-01, IS REGISTERED AND SOLD IN THE UNITED STATES. THE LOT IMPACTED BY THIS COMPLAINT IS PART OF THE SCOPE OF FSCA #(B)(4) FOR INVALID CALIBRATION ON VIDAS CMV IGM 30 TESTS (REF. 30205 AND 30205-01) THAT WAS RELEASED ON 04-FEB-2022.

Additional Manufacturer Narrative

BASED ON AN INCREASING RATE OF COMPLAINTS FOR INVALID CALIBRATION, BIOMÉRIEUX INITIATED AN INVESTIGATION. THOUGH THE ROOT CAUSE OF THE INVALID CALIBRATION IS CURRENTLY UNDER INVESTIGATION, IT HAS BEEN DECIDED TO ISSUE FSCA # (B)(4).. TO DATE INTERNAL TESTING HAS NOT REPLICATED THE INVALID CALIBRATIONS. NOTE: THIS SITUATION DOES NOT PRESENT A RISK OF A FALSE RESULT. IF THE CALIBRATION IS INVALID THE USER HAS AN ALERT ON THE EQUIPMENT THAT HE CANNOT GIVE PATIENT RESULTS. ADDITIONALLY, THE VIDAS® CMV IGM PACKAGE INSERT ¿CALIBRATION¿ SECTION STATES, "CALIBRATION USING THE STANDARD PROVIDED IN THE KIT MUST BE PERFORMED EACH TIME A NEW LOT OF REAGENTS IS OPENED, AFTER THE MASTER LOT DATA HAVE BEEN ENTERED." THE RISK PRESENTED IS THE POTENTIAL FOR A DELAYED RESULT. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

BIOMÉRIEUX RECEIVED SEVERAL COMPLAINTS ABOUT CALIBRATION ISSUE (THE CALIBRATOR VALUES ARE OUT OF RANGE TOO HIGH) OBSERVED ON VIDAS® CMV IGM (REF 30205 ; 30205-01). AN INTERNAL INVESTIGATION HAS BEEN MANAGED BY A MULTIDISCIPLINARY TEAM INVOLVING SEVERAL DEPARTMENTS (MANUFACTURING SITE, R&D AND GLOBAL CUSTOMER SERVICE) WITH THE FOLLOWING RESULTS. 1. INVESTIGATION. A. BATCH HISTORY RECORDS. THE ANALYSIS OF THE BATCH HISTORY RECORDS FOR THE CONCERNED VIDAS® CMV IGM LOTS DIDN¿T SHOW ANY ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. B. INVESTIGATION DETAILS. - INVESTIGATIONS PERFORMED ON PRE-ANALYTICAL STEPS, INSTRUMENT, STORAGE AND TRANSPORTATION OF THE KITS DO NOT SHOW ANY ANOMALY THAT COULD EXPLAIN THE ISSUE. FOR LOTS IMPACTED BY THE PREVIOUS FSCA 5109, INVALID CALIBRATIONS WERE NOT CONFIRMED ON EITHER CUSTOMER¿S KITS NOR ON RETAINED KITS. THE RFV VALUES OBTAINED DURING THIS INVESTIGATION WERE NEAR TO THE HIGHER LIMIT OF THE RANGE WITHOUT NON-CONFORMING RESULTS. A DESIGN OF EXPERIMENTS (DOE) WAS DONE WITH A FOCUS ON THE CALIBRATOR S1 TO TRY TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. HOWEVER, IT DIDN¿T LEAD TO THE ROOT CAUSE IDENTIFICATION. THE INVESTIGATION CONFIRMED THAT THE CALIBRATOR¿S VALUE INCREASES DURING THE FIRST FEW DAYS AFTER PRODUCTION. THE ISSUE SEEMS TO BE LINKED TO THE NEW BIOLOGICAL STANDARD S1 FORMULATION (HUMAN FREE SERA) IMPLEMENTED SINCE APRIL 2019. ADDITIONAL STABILIZATION TIME OF THE BULK CONJUGATE USED IN STRIPS HAS BEEN IMPLEMENTED IN ORDER TO BALANCE EVOLUTION OF NEW S1 FORMULATION. FOR LOTS IMPACTED BY THIS FSCA 5537, INVALID CALIBRATIONS WERE NOT CONFIRMED INTERNALLY ON EITHER CUSTOMER¿S KITS NOR ON RETAINED KITS. AN INVESTIGATION WAS CARRIED OUT IN A LABORATORY OF A CUSTOMER EXPERIENCING THE PROBLEM. THE CALIBRATION ISSUE WAS REPRODUCED ON LOT 1008873250. THE CUSTOMER INSTRUMENT WAS INVESTIGATED BUT NO ISSUE WAS DETECTED. THE LABORATORY ENVIRONMENT WAS SUSPECTED AS THERE WAS A HIGH TEMPERATURE OBSERVED AT THE CUSTOMER LABORATORY DURING THE VISIT. INTERNAL TESTS WERE DONE AT HIGH TEMPERATURE: THE HIGH TEMPERATURE (ENVIRONMENT) FACTOR WAS NOT CONFIRMED. THE HYPOTHESIS IS THE ASSOCIATION OF SPECIFIC RAW MATERIALS OF THE CONJUGATE DILUENT USED IN THE CONJUGATE SOLUTION, PART OF THE STRIPS OF THE CONCERNED LOTS. AS THERE IS NO MORE RAW MATERIAL REMAINING FOR FURTHER INVESTIGATION, THIS HYPOTHESIS CANNOT BE VALIDATED AND FURTHER INVESTIGATED. IN CONCLUSION, THE STABILIZATION ACTION BEFORE RELEASE ALLOWED TO LIMIT THE CALIBRATION ISSUE ON THE FIELD AND TO RETURN TO A NORMAL TREND FOR THIS ISSUE TO DATE.