VIDAS BRAHMS PROCALCITONIN 60T

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER IN UNITED-STATES OF OUT OF RANGE HIGH RESULTS WHEN TESTING WITH VIDAS® BRAHMS PROCALCITONIN 60T (REF. 30450-01, LOT #1008448080, EXPIRY DATE: 24-MAY-2022) IN CONTEXT OF CAP SURVEY USING EXTERNAL QUALITY CONTROL (CAP SURVEY SAMPLE PCT-02). **INVESTIGATION** 1. DEVICE HISTORY RECORD THE REVIEW DID NOT HIGHLIGHT ANY ISSUE DURING MANUFACTURING FOR VIDAS® PCT REF. 30450-01 LOT 1008448080. 2. COMPLAINT ANALYSIS THE COMPLAINT ANALYSIS DID NOT REVEAL THIS ISSUE AS A SYSTEMIC QUALITY ISSUE. 3.ANALYSIS PERFORMED **PRODUCT RETURN** THERE IS NO REMAINING VOLUME FOR THE CUSTOMER SAMPLE PCT-02. **INVESTIGATION PROTOCOL AND AND OBTAINED RESULTS** **CONTROL CHARTS ANALYSIS** THE ANALYSIS OF THE CONTROL CHARTS PERFORMED ON FOUR (4) INTERNAL SAMPLES (TARGET AT 0.30, 0.34, 0.87 AND 1.22 NG/ML) AND SEVEN (7) LOTS INCLUDING CUSTOMER¿S LOT 1008448080 SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS. CUSTOMER¿S LOT IS IN THE TREND COMPARED TO THE OTHER LOTS. 2. INVESTIGATION **TESTS PERFORMED** ** INTERNAL SAMPLES** THREE (3) SAMPLES TARGETED AT 0.27, 0.34 AND 0.87 NG/ML WERE TESTED WITH VIDAS® PCT LOT 1008448080 (CUSTOMER¿S LOT). => ALL SAMPLES TESTED WERE COMPLIANT WITH THEIR SPECIFICATION AND THE RESULTS WERE SIMILAR TO THOSE OBTAINED BEFORE THE BATCH RELEASE. ** CAP SURVEY EXTERNAL QUALITY CONTROL ** THE COMPLAINTS LABORATORY SUBSCRIBES TO CAP SURVEY EQA SCHEME AND TESTS THOSE QUALITY CONTROL SAMPLES SUCH AS AN ORDINARY USER. THE SAMPLE PCT-02 WAS TESTED AT THE TIME OF CAP SURVEY ASSESSMENT WITH VIDAS® PCT BATCH 1008538020 AND WE OBTAINED THE FOLLOWING RESULT: PCT-02 = 7.92 NG/ML CAP SURVEY SPECIFICATION RANGE [6.49-8.80] NG/ML FOR THIS INVESTIGATION, PCT-02 SAMPLE WAS TESTED WITH VIDAS® PCT LOT 1008448080 PCT-02 = 7.43 NG/ML => THE CUSTOMER¿S RESULT WAS NOT REPRODUCED INTERNALLY WHEN TESTING PCT-02 SAMPLE WITH VIDAS® PCT LOT 1008448080 (CUSTOMER¿S LOT) AND ANOTHER LOT 1008538020. THE RESULTS OBTAINED ON BOTH LOTS WERE NOT SIGNIFICANTLY DIFFERENT. 3. ROOT CAUSE ANALYSIS ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED ON THE RETAIN KIT VIDAS® PCT LOT 1008448080 USING INTERNAL SAMPLES AND CAP SURVEY EXTERNAL QUALITY CONTROL MATERIALS. WE DID NOT REPRODUCED THE CUSTOMER¿S ISSUE WITH THE SAME CAP SURVEY MATERIAL, IE PCT-02 SAMPLE. THEREFORE THE MAINLY HYPOTHESIS IS A PREANALYTICAL ISSUE AT CUSTOMER¿S LEVEL. ACCORDING TO THE ABOVE DATA, KIT VIDAS® PCT REF. 30450-01 LOT 1008448080 IS WITHIN THE EXPECTED PERFORMANCES.

Description of Event or Problem

INTENDED USE : VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) 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¿ IS INTENDED FOR USE AS FOLLOWS: 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, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATIENTS WITH SUSPECTED OR CONFIRMED SEPSIS. DESCRIPTION OF THE ISSUE : ON 08-OCT-2021, A CUSTOMER IN UNITED-STATES NOTIFIED BIOMÉRIEUX OF OUT OF RANGE HIGH RESULTS WHEN TESTING WITH VIDAS® BRAHMS PROCALCITONIN 60T (REF. 30450-01, LOT #1008448080, EXPIRY DATE: 24-MAY-2022) IN CONTEXT OF CAP SURVEY USING EXTERNAL QUALITY CONTROL. TO BE NOTED THAT THE CLIENT OBSERVED THE SAME ISSUE WITH ANOTHER LOT (LOT #1008647850). THIS CASE HAS BEEN REPORTED SEPARATELY ((B)(4)). FOR THE SURVEY COMPLETED ON (B)(6) 2021 ON PCT LOT #1008647850, WHICH WAS CALIBRATED (B)(6) 2021, THE CLIENT OBTAINED THE FOLLOWING RESULTS: FOR THE SURVEY COMPLETED ON (B)(6) 2021 ON PCT LOT #1008448080 WHICH WAS CALIBRATED ON (B)(6) 2021. RFV 2878 (RANGE 2154 - 3856; MEAN 3000), RFV 445 (RANGE 336 - 600; MEAN 468), 19.60 NG/ML (RANGE 15.41 - 24.07 NG/ML),AND 2.10 NG/ML (RANGE 1.54 - 2.48 NG/ML). THEIR CAP SURVEY RESULTS: PCT-01 0.43 NG/ML (CAP ACCEPTABLE RANGE 0.30 - 0.55 NG/ML), PCT-02 9.26 NG/ML (CAP ACCEPTABLE RANGE 6.49 - 8.80 NG/ML) OUT OF RANGE HIGH, AND PCT -03 2.40 NG/ML (CAP ACCEPTABLE RANGE 1.99 - 2.86 NG/ML). AS IT WAS A QUALITY CONTROL SAMPLE, NO PATIENT SAMPLE WAS INVOLVED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH NOR ANY DELAYED RESULT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

Description of Event or Problem

INTENDED USE : VIDAS® B·R·A·H·M·S PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) 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¿ IS INTENDED FOR USE AS FOLLOWS: 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, TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME, TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCHITIS, AND ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (AECOPD) ¿ IN AN INPATIENT SETTING OR AN EMERGENCY DEPARTMENT, TO AID IN DECISION MAKING ON ANTIBIOTIC DISCONTINUATION FOR PATIENTS WITH SUSPECTED OR CONFIRMED SEPSIS. DESCRIPTION OF THE ISSUE : ON 08-OCT-2021, A CUSTOMER IN UNITED-STATES NOTIFIED BIOMÉRIEUX OF OUT OF RANGE HIGH RESULTS WHEN TESTING WITH VIDAS® BRAHMS PROCALCITONIN 60T (REF. (B)(4), LOT #1008448080, EXPIRY DATE: 24-MAY-2022) IN CONTEXT OF CAP SURVEY USING EXTERNAL QUALITY CONTROL. TO BE NOTED THAT THE CLIENT OBSERVED THE SAME ISSUE WITH ANOTHER LOT (LOT #1008647850). THIS CASE HAS BEEN REPORTED SEPARATELY ((B)(4)). FOR THE SURVEY COMPLETED ON (B)(6) 2021 ON PCT LOT #1008647850, WHICH WAS CALIBRATED (B)(6) 2021, THE CLIENT OBTAINED THE FOLLOWING RESULTS: FOR THE SURVEY COMPLETED ON (B)(6) 2021 ON PCT LOT #1008448080 WHICH WAS CALIBRATED ON (B)(6) 2021. RFV 2878 (RANGE 2154 - 3856; MEAN 3000), RFV 445 (RANGE 336 - 600; MEAN 468), 19.60 NG/ML (RANGE 15.41 - 24.07 NG/ML),AND 2.10 NG/ML (RANGE 1.54 - 2.48 NG/ML). THEIR CAP SURVEY RESULTS: PCT-01 0.43 NG/ML (CAP ACCEPTABLE RANGE 0.30 - 0.55 NG/ML), PCT-02 9.26 NG/ML (CAP ACCEPTABLE RANGE 6.49 - 8.80 NG/ML) OUT OF RANGE HIGH, AND PCT -03 2.40 NG/ML (CAP ACCEPTABLE RANGE 1.99 - 2.86 NG/ML). AS IT WAS A QUALITY CONTROL SAMPLE, NO PATIENT SAMPLE WAS INVOLVED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH NOR ANY DELAYED RESULT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.