VIDAS® BRAHMS PROCALCITONIN 60T

Description of Event or Problem

PRODUCT DESCRIPTION: VIDAS® B·R·A·H·M·S PCT¿ IS AN AUTOMATED TEST FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ AIDS IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION, FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ ALSO AIDS IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH LOWER RESPIRATORY TRACT INFECTIONS (LRTI) (INCLUDING COMMUNITY ACQUIRED PNEUMONIA, EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ACUTE BRONCHITIS) SEEN DURING MEDICAL CONSULTATIONS, INCLUDING AT THE EMERGENCY DEPARTMENT. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING SUBSTRATE ERROR WHEN USING VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450, BATCH NUMBER: 1008661450). INDEED CUSTOMER REPORTED SUBSTRATE ERROR WITH SEVERAL STRIPS (OPT: 367 AND 369). TO BE NOTED THAT IN CASE OF SUBSTRATE ERROR, AN ERROR MESSAGE IS DISPLAYED ON THE EQUIPMENT VISIBLE BY THE USER, AND IT IS IMPOSSIBLE TO RUN TESTS AND GENERATE RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE SUBSTRATE ERROR LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AT THE TIME OF THIS ASSESSMENT, THERE IS NO INFORMATION REGARDING DELAYS FOR ANY PATIENT SAMPLES. HOWEVER, IF THE CUSTOMER DOES NOT HAVE AN ALTERNATIVE TESTING METHOD, THIS COULD POTENTIALLY LEAD TO DELAYED PATIENT TEST RESULTS. THE LOT IMPACTED BY THIS COMPLAINT IS PART OF THE SCOPE OF FSCA # (B)(4) FOR SUBSTRATE ERROR ON MULTIPLE VIDAS PRODUCT REFERENCES THAT WAS RELEASED ON 22-SEP-2021. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: REFERENCE 30450 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30450-01.

Additional Manufacturer Narrative

SINCE JULY 2021, BIOMÉRIEUX HAS BEEN RECEIVING AN INCREASING NUMBER OF COMPLAINTS LINKED TO A VIDAS® ¿SUBSTRATE ERROR¿. IT PREVENTS THE TEST FROM BEING RUN, THEREFORE LEADS TO POTENTIAL DELAYED RESULTS AS THE USER MUST RUN ANOTHER TEST. A MEASUREMENT OF THE BACKGROUND NOISE SIGNAL (RFU) IS MADE BY THE VIDAS® SYSTEM PRIOR TO LAUNCHING THE REACTION. AN ACCEPTABLE LIMIT IS DEFINED DURING PRODUCT DESIGN FOR EACH REFERENCE OF FINISHED GOODS. THREE VALUES EXIST AS ACCEPTABLE LIMITS DEPENDING ON THE ASSAY: 300, 350 AND 500 RFU. THE SUBSTRATE IS PRESENT IN THE LAST WELL OF THE STRIP OF ALL VIDAS® IMMUNO-ASSAYS AND ALLOWS FLUORESCENCE WHEN DEGRADED BY THE ENZYME (PAL). THE LEVEL OF FLUORESCENCE IS THEN CORRELATED WITH THE RESULTS OF ALL TESTS. WHEN PERFORMING A TEST, IF THE RFU IS HIGHER THAN THE ACCEPTABLE LIMIT DEFINED DURING THE PRODUCT DEVELOPMENT, THERE IS AN ERROR MESSAGE DISPLAYED BY THE SYSTEM: ¿SUBSTRATE ERROR¿. THE TEST IS STOPPED AND THIS ALARM PREVENTS THE SYSTEM FROM PROVIDING ANY RESULT. WITH THIS ALARM BEING PRESENT ON ALL THE SYSTEMS OF THE VIDAS® FAMILY, IT GUARANTEES THAT NO FALSE RESULTS CAN BE GIVEN IN CASE OF A SUBSTRATE DEGRADATION. THERE IS A POTENTIAL RISK OF DELAYED RESULTS. DESCRIPTION OF THE INVESTIGATION AND ROOT CAUSE ANALYSIS: INVESTIGATIONS WERE IMMEDIATELY INITIATED TO IDENTIFY THE ROOT-CAUSE, THE FOLLOWING WERE IDENTIFIED: ALL LOTS IMPACTED OF VIDAS® IMMUNO-ASSAYS WERE CONFORM TO THE SPECIFICATIONS AT RELEASE. THE SUBSTRATE ERROR ISSUE WAS CONFIRMED ON ALL LOTS OF VIDAS® IMMUNO-ASSAYS MANUFACTURED WITH SUBSTRATE BATCHES USING A COMMON LOT OF RAW MATERIAL (4-MUP) THAT WAS IDENTIFIED AS THE MOST PROBABLE COMMON ROOT-CAUSE. THE SCOPE OF THE ISSUE WAS IDENTIFIED ON ALL LOTS OF VIDAS® IMMUNO-ASSAYS MANUFACTURED SINCE FEBRUARY 2021 USING SUBSTRATE BATCHES MANUFACTURED WITH THIS CONCERNED LOT OF RAW MATERIAL. THE PROBLEM IS DUE TO AN ACCELERATED DEGRADATION OF THE SUBSTRATE. IT FOLLOWS A LINEAR MODEL OVER TIME LEADING TO RFU ACCEPTABLE LIMITS BEING REACHED BEFORE THE END OF THE REGISTERED SHELF LIFE OF THE PRODUCT. KINETIC EVOLUTION ANALYSES WERE PERFORMED BY MEASURING SUBSTRATE RFU OF A STATISTICALLY REPRESENTATIVE NUMBER OF VIDAS® IMMUNO- ASSAYS RETAINED BATCHES (MANUFACTURED WITH THE SUBSTRATE CONTAINING THE CONCERNED RAW MATERIAL) AT DIFFERENT SHELF-LIVES. THE MODEL WAS VALIDATED ON NUMEROUS DATA (~ 450 000) COLLECTED FROM THE FIELD (CUSTOMERS) . THE ANALYSIS OF THE KINETIC MODEL ALLOWS US TO PREDICT THE DEGRADATION TREND OF THE SUBSTRATE USING THE CONCERNED BATCH OF 4MUP AND THEREFORE TO REVISE THE EXPIRY DATES FOR EACH LOT OF IMPACTED VIDAS® IMMUNO- ASSAYS FINISHED PRODUCTS. WHEN USED UNTIL THE REVISED EXPIRY DATE, THE PRODUCT CONTINUES TO PERFORM PER ITS REGISTERED PERFORMANCE SPECIFICATIONS. WHEN AN ERROR MESSAGE ¿SUBSTRATE ERROR¿ IS DISPLAYED BY THE VIDAS® SYSTEM, THE TEST IS STOPPED AND THIS ALARM PREVENTS THE SYSTEM FROM PROVIDING ANY RESULT. THE INABILITY TO PROVIDE A RESULT IN A TIMELY MANNER (POTENTIAL DELAYED RESULTS) MAY HAVE AN IMPACT ON PATIENT MANAGEMENT DEPENDING ON WHETHER OR NOT THERE ARE CLEAR MANAGEMENT OR TREATMENT STRATEGIES THAT RELY SOLELY OR MOSTLY ON THE TEST RESULT; WHETHER OR NOT THE MANAGEMENT STRATEGY CAN BE DELAYED, AND FOR HOW LONG; WHETHER OR NOT THERE ARE ASSAYS FROM A LOT NOT IMPACTED BY THE ISSUE THAT ARE AVAILABLE; WHETHER OR NOT THE LABORATORY IS ABLE TO USE AN ALTERNATIVE METHOD. THEREFORE, A CORRECTIVE ACTION INVOLVING A REVISED EXPIRATION DATE FOR ALL IMPACTED LOTS OF CLINICAL VIDAS® IMMUNO-ASSAYS PRODUCTS IS REQUIRED TO ENSURE THAT THE SPECIFIED PRODUCTS WILL CONTINUE TO PERFORM PER LABELLED PERFORMANCE SPECIFICATIONS. THE INVESTIGATION IS ONGOING.