VIDAS® BRAHMS PROCALCITONIN

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 INSTRUMENTS FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. THE VIDAS® B·R·A·H·M·S PCT¿ IS INTENDED FOR USE IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK. RANGE OF EXPECTED VALUES: IN AGREEMENT WITH THE LITERATURE (3, 4), THE RESULTS OBTAINED WITH VIDAS® B·R·A·H·M·S PCT¿ DURING A STUDY PERFORMED ON PATIENTS ADMITTED TO INTENSIVE CARE UNITS (REFER TO ¿CLINICAL PERFORMANCE¿ SECTION) ARE AS FOLLOWS: - A CONCENTRATION < 0.5 NG/ML REPRESENTS A LOW RISK OF SEVERE SEPSIS AND/OR SEPTIC SHOCK. - A CONCENTRATION > 2 NG/ML REPRESENTS A HIGH RISK OF SEVERE SEPSIS AND/OR SEPTIC SHOCK. NEVERTHELESS, CONCENTRATIONS < 0.5 NG/ML DO NOT EXCLUDE AN INFECTION, ON ACCOUNT OF LOCALIZED INFECTIONS (WITHOUT SYSTEMIC SIGNS) WHICH CAN BE ASSOCIATED WITH SUCH LOW CONCENTRATIONS, OR A SYSTEMIC INFECTION IN ITS INITIAL STAGES (< 6 HOURS). FURTHERMORE, INCREASED PROCALCITONIN CAN OCCUR WITHOUT INFECTION. PCT CONCENTRATIONS BETWEEN 0.5 AND 2.0 NG/ML SHOULD BE INTERPRETED TAKING INTO ACCOUNT THE PATIENT¿S HISTORY. IT IS RECOMMENDED TO RETEST PCT WITHIN 6-24 HOURS IF ANY CONCENTRATIONS < 2 NG/ML ARE OBTAINED. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER FROM CHINA NOTIFIED BIOMÉRIEUX OF OBTAINING POTENTIAL FALSE POSITIVES RESULTS WHEN TESTING PATIENT SAMPLES WITH VIDAS BRAHMS PROCALCITONIN (REF. (B)(4), LOT: 1010775940, EXPIRY DATE: 25-NOV-2025). THE CUSTOMER TESTED TWO (2) PATIENT SAMPLES WITH VIDAS BRAHMS PROCALCITONIN (REF. (B)(4), LOT: 1010775940) AND OBTAINED THE FOLLOWING RESULTS: ON (B)(6) 2025 - PATIENT #1: FIRST TEST: 59.5NG/ML SECOND TEST: < 0.05NG/ML ON (B)(6) 2025 - PATIENT #2: FIRST TEST: 0.73NG/ML SECOND TEST: < 0.05NG/ML THE CUSTOMER REPORTED THAT THERE WAS NO DELAY NOR WRONG REPORT FOR THE PATIENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE (B)(4) IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE (B)(4).

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A NOTIFICATION FROM A CUSTOMER FROM CHINA WHO OBTAINED POTENTIAL FALSE POSITIVES RESULTS WHEN TESTING PATIENT SAMPLES WITH VIDAS BRAHMS PROCALCITONIN (REF. (B)(4), LOT: 1010775940, EXPIRY DATE: 25-NOV-2025). 1) COMPLAINT ANALYSIS THE COMPLAINT ANALYSIS DID NOT REVEAL THIS ISSUE AS A SYSTEMIC QUALITY ISSUE. 2) QUALITY CONTROL RECORDS THERE IS NEITHER CAPA , NON-CONFORMITY NOR QUALITY EVENT LINKED TO THIS ISSUE RECORDED ON THIS VIDAS ASSAY. 3) ANALYSIS AND TESTS CONDUCTED BY COMPLAINTS LABORATORY. 3.1) CONTROL CHART ANALYSIS THIS ANALYSIS WAS CARRIED OUT: - ON FOUR (4) INTERNAL SAMPLES WITH A RESPECTIVE TARGET AT 0.15, 0.33, 0.34 AND 7.80 G/L; - ON SEVEN (7) BATCHES OF VIDAS® B·R·A·H·M·S PCT¿ (PCT) REF (B)(4) INCLUDING THE LOT 1010775940 MENTIONED BY THE CUSTOMER. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS. WE DO NOT OBSERVE ANY TREND OF THIS LOT COMPARED TO THE OTHER LOTS. 3.2) TESTS PERFORMED USING INTERNAL SAMPLES THE COMPLAINTS LABORATORY TESTED 4 INTERNAL SAMPLES (TARGETED AT 0.07, 0.34, 10.1 AND 40.9 ¿G/L) ON VIDAS® B·R·A·H·M·S PCT¿ REF (B)(4) LOT 1010775940 (RETAIN KIT). ALL SAMPLES GAVE RESULTS WITHIN ACCEPTANCE CRITERIA AND SHOWED TO GIVE NO SIGNIFICANT DIFFERENCE COMPARED TO THE RESULTS OBSERVED BEFORE THE BATCH RELEASE. WE DID NOT OBSERVE ANY EVOLUTION OVER TIME OF THEIR ACTIVITY SINCE THE BATCH RELEASE. 3.3) TESTS PERFORMED USING FRESH SERA THE COMPLAINTS LABORATORY TESTED TWO (2) FRESH SERA FROM ETABLISSEMENT FRANÇAIS DU SANG (EFS) FIVE (5) TIMES ON RETAIN KIT VIDAS® B·R·A·H·M·S PCT¿ REF (B)(4) LOT 1010775940. ALL RESULTS ARE COMPLIANT WITHOUT ANY REPRODUCIBILITY ISSUE. 4) ROOT CAUSE ANALYSIS AND CONCLUSION ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED ON RETAIN KIT VIDAS® B·R·A·H·M·S PCT¿ REF (B)(4) LOT 1010775940 USING INTERNAL SAMPLES. CUSTOMER¿S ISSUE, I.E. NONREPRODUCIBLE OVERESTIMATED RESULTS, WERE NOT REPRODUCED DURING THE INVESTIGATION CONDUCTED ON INTERNAL SAMPLES OR FRESH SERA FROM ETABLISSEMENT (B)(4). AN OPERATOR ERROR HYPOTHESIS RELATED TO THE ABSENCE OF SPRS OR SAMPLE COULD NOT BE EXCLUDED. ACCORDING TO THE ABOVE DATA, THE PERFORMANCE OF VIDAS® B·R·A·H·M·S PCT¿ REF (B)(4) LOT 1010775940 IS CONFORM TO THE EXPECTED SPECIFICATIONS.