VIDAS® B¿R¿A¿H¿M¿S PCT¿

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. RANGE OF EXPECTED VALUES RISK ASSESSMENT FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK IN AGREEMENT WITH THE LITERATURE, THE RESULTS OBTAINED WITH VIDAS® B¿R¿A¿H¿M¿S PCT¿ DURING A STUDY PERFORMED ON PATIENTS ADMITTED TO INTENSIVE CARE UNITS 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 KUWAIT NOTIFIED BIOMÉRIEUX OF OBTAINING NON-REPRODUCIBLE RESULTS WHEN USING VIDAS® BRAHMS PROCALCITONIN 60T (REF. 30450, LOT: 1010992790, EXPIRY DATE: 09-APR-2026). THE CUSTOMER USES A VIDAS® KUBE INSTRUMENT (SERIAL NO. (B)(6). THE CUSTOMER TESTED ONE (1) PATIENT SAMPLE WITH VIDAS® BRAHMS PROCALCITONIN 60T (REF. 30450, LOT: 1010992790) TWO (2) TIMES. THE PATIENT WAS TESTED FOR A SUSPECTED SEPSIS CASE. THE FOLLOWING RESULTS WERE OBTAINED: FIRST TEST: 2.54 NG/ML. SECOND TEST: < 0.05 NG/ML. THE CUSTOMER REPORTED ENCOUNTERING THESE NON-REPRODUCIBLE RESULTS WITH OTHER SAMPLES, BUT THEY DID NOT WISH TO PROVIDE ANY MORE DETAIL REGARDING THE ISSUE. THEREFORE, THE NUMBER OF PATIENTS IMPACTED OR ANY DETAILS REGARDING OTHER SAMPLES ARE NOT KNOWN. BASED ON THE AVAILABLE INFORMATION AT THE TIME OF THIS ASSESSMENT, THERE WAS NO REPORT OF ANY POTENTIAL PATIENT¿S IMPACT OF THIS ISSUE, OR ANY DELAYED OF RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE 30450 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30450-01.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN KUWAIT REGARDING NON-REPRODUCIBLE RESULTS WHEN TESTING ONE (1) PATIENT SAMPLE WITH VIDAS® B·R·A·H·M·S PROCALCITONIN 60T (REF. 30450, LOT: 1010992790, EXPIRY DATE: 09-APR-2026). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: 1.DEVICE HISTORY RECORDS THE REVIEW DID NOT HIGHLIGHT ANY ISSUE DURING THE MANUFACTURING PROCESS OF VIDAS® B·R·A·H·M·S PROCALCITONIN 60T (REF. 30450, LOT: 1010992790). 2. COMPLAINT ANALYSIS AT THE DATE OF INVESTIGATION, NO OTHER COMPLAINTS WERE RECORDED FOR REPRODUCIBILITY ISSUE ON VIDAS® B·R·A·H·M·S PROCALCITONIN 60T (REF. 30450, LOT: 1010992790). 3. ANALYSIS AND TESTS CONDUCTED BY COMPLAINTS LABORATORY 3.1 CUSTOMERS MATERIAL NO SAMPLE/LOT WERE RECEIVED FROM THE CUSTOMER. 3.2 CONTROL CHART ANALYSIS THIS ANALYSIS WAS CARRIED OUT: - ON FOUR (4) INTERNAL SAMPLES WITH THE FOLLOWING TARGETS 0.15 / 0.34 / 1.46 AND 3.68 NG/ML. - ON SEVEN (7) BATCHES OF VIDAS® B·R·A·H·M·S PROCALCITONIN 60T (REF. 30450) INCLUDING THE LOT 1010992790 MENTIONED BY THE CUSTOMER. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS AND THE LOT MENTIONED BY THE CUSTOMER (LOT 1010992790) IS IN THE TREND COMPARED TO THE OTHER LOTS. 3.3 TESTS ON INTERNAL SAMPLES THE COMPLAINTS LABORATORY TESTED THREE (3) INTERNAL SAMPLES WITH THE FOLLOWING TARGETS 0.07, 0.33 AND 3.22 NG/ML ON THE RETAIN KIT OF VIDAS® B·R·A·H·M·S PROCALCITONIN 60T (REF. 30450, LOT: 1010992790). THE RESULTS COMPLIED TO THE SPECIFICATIONS. THE RESULTS WERE CLOSE TO THE RESPECTIVE TARGET OF EACH SAMPLE WITHOUT ANY SIGNIFICANT DIFFERENCE COMPARED TO THE ONES OBSERVED BEFORE THE BATCH RELEASE. NO EVOLUTION OVER TIME OF THEIR ACTIVITY WAS OBSERVED. 3.4 REPEATABILITY TESTING TEN (10) SAMPLES FROM A FRENCH BLOOD DONOR CENTER WERE TESTED DURING TWO (2) RUNS AND THE RESULTS WERE COMPARED BETWEEN THE TWO (2) RUNS : ALL THE RESULTS WERE < 0.05 NG/ML FOR BOTH RUNS. NO REPRODUCIBILITY ISSUE NOR OVERESTIMATED RESULTS WERE OBSERVED WITH THESE SAMPLES. 4. CONCLUSION NO ISSUES WERE HIGHLIGHTED WHEN ANALYZING ALL THE DATA AND NEITHER THE REPRODUCIBILITY ISSUE NOR OVERESTIMATED RESULTS WERE REPRODUCED WHEN TESTING INTERNAL SAMPLES OR SAMPLES FROM BLOOD DONOR. UNFORTUNATELY, WITHOUT ANY MATERIAL FROM CUSTOMER, IT WAS NOT POSSIBLE TO PURSUE FURTHER THE INVESTIGATION. ONE (1) CRITICAL POINT TO EMPHASIZE IN THE PREANALYTICAL STEPS IS THE COAGULATION TIME. THE CUSTOMER MENTIONED THAT IT WAS APPROXIMATELY FIVE (5) MINUTES, WHICH IS INSUFFICIENT TO ENSURE SAMPLE QUALITY. COAGULATION TIME PLAYS A VITAL ROLE IN THE RELIABILITY OF THE ANALYSIS. INADEQUATE COAGULATION CAN LEAD TO THE PRESENCE OF MICROCLOTS, FIBRIN STRANDS, OR FRAGMENTED CELLS, ALL OF WHICH MAY INTERFERE WITH THE ANALYTICAL PROCESS. THIS HIGHLIGHTS THE IMPORTANCE OF STRICTLY ADHERING TO PREANALYTICAL PROTOCOLS TO ACHIEVE REPRODUCIBLE AND ACCURATE RESULTS IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS® B·R·A·H·M·S PROCALCITONIN 60T (REF. 30450) THE FOLLOWING INFORMATION AT SECTION: SPECIMENS: SAMPLE PREPARATION: ¿FOR SERUM SPECIMENS, ENSURE THAT COMPLETE CLOT FORMATION HAS TAKEN PLACE PRIOR TO CENTRIFUGATION. SAMPLES CONTAINING SUSPENDED FIBRIN PARTICLES OR ERYTHROCYTE STROMA SHOULD BE CENTRIFUGED BEFORE TESTING.¿ ACCORDING TO THE ABOVE DATA, THE PERFORMANCE OF THE VIDAS® B·R·A·H·M·S PROCALCITONIN 60T (REF. 30450, LOT: 1010992790) IS CONFORM TO THE EXPECTED SPECIFICATIONS.