VIDAS® BRAHMS PROCALCITONIN 60T

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER IN UNITED STATES OF OUT OF RANGE LOW RESULT WHEN TESTING VIDAS® BRAHMS PROCALCITONIN 60T (REF. (B)(4), LOT #1008544030, EXPIRY DATE: 25-JUL-2021) IN CONTEXT OF PROFICIENCY SAMPLE ASSAY. CUSTOMERS MATERIAL: NO SAMPLE RECEIVED FROM CUSTOMER. INVESTIGATION OUTCOMES: 1) COMPLAINT ANALYSIS THE COMPLAINT ANALYSIS DID NOT REVEAL THIS ISSUE AS A SYSTEMIC QUALITY ISSUE. 2) QUALITY CONTROL RECORDS: THE REVIEW OF THE DIFFERENT QUALITY CONTROL RECORDS DID NOT HIGHLIGHT ANY ISSUE DURING MANUFACTURING, CONTROL AND PACKAGING PROCESSES ON VIDAS® B.R.A.H.M.S PCT LOT 1008544030. 3) ANALYSIS AND TESTS CONDUCTED BY COMPLAINTS LABORATORY CONTROL CHART ANALYSIS: THIS ANALYSIS WAS CARRIED OUT: ON FOUR (4) INTERNAL SAMPLES WITH A RESPECTIVE TARGET AT 0.87 / 1.22 / 3.03 AND 3.92 NG/ML. THE COMPLAINTS LABORATORY SELECTED THESE SAMPLES BECAUSE THEIR CONCENTRATIONS WERE CLOSED TO THE EXPECTED LEVEL OF QUALITY CONTROL SAMPLES FROM API. ON TEN (10) BATCHES OF VIDAS® B.R.A.H.M.S PCT REF. (B)(4) INCLUDING LOT 1008544030 MENTIONED BY THE CUSTOMER. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS AND VIDAS® B.R.A.H.M.S PCT LOT 1008544030 IS GLOBALLY IN THE TREND COMPARED TO THE OTHER LOTS. TEST ON INTERNAL SAMPLES: THE COMPLAINTS LABORATORY TESTED THE FOUR (4) INTERNAL SAMPLES MENTIONED ABOVE ON VIDAS® B.R.A.H.M.S PCT LOT 1008544030. THE RESULTS COMPLIED WITH THE SPECIFICATIONS AND GAVE SIMILAR RESULTS COMPARED TO THOSE OBSERVED BEFORE THE BATCH RELEASE. WE DID NOT OBSERVE ANY EVOLUTION OVER TIME OF THESE SAMPLES ACTIVITY. ANALYSIS OF REPORT OF ANOTHER EXTERNAL QUALITY PROGRAM: OUR COMPLAINTS LABORATORY ORDERS QUALITY CONTROL SAMPLES TO AUDIT MICRO CONTROL COMPANY IN THE CONTEXT OF LINEARITY AND CALIBRATION VERIFICATION. THESE SAMPLES WERE TESTED IN (B)(6) 2021 ON VIDAS B.R.A.H.M.S PCT LOT 1008544030. THE ANALYSIS OF RESULTS DOES NOT HIGHLIGHT SIMILAR BEHAVIOR AS THE ONE DESCRIBED BY THE CUSTOMER (RESULTS OUT OF RANGE TOO LOW). CONCLUSION: THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE CUSTOMER¿S ANOMALY, NAMELY RESULTS OUT OF RANGE TOO LOW WHEN TESTING INTERNAL SAMPLES ON VIDAS B.R.A.H.M.S PCT LOT 1008544030, NOR WHEN TESTING THE SET OF QUALITY CONTROL SAMPLES FROM AUDIT MICRO CONTROL. NO OBVIOUS ROOT CAUSE WAS IDENTIFIED. HOWEVER, THE ISSUE COULD HAVE BEEN DUE TO AN ISSUE DURING THE PRE-ANALYTICAL PHASE. THE CUSTOMER MENTIONED THE POSSIBILITY OF AN OPERATOR ERROR DURING THE RECONSTITUTION OF THE CONCERNED QUALITY CONTROL SAMPLE (USE OF SALINE SOLUTION INSTEAD OF DISTILLED WATER). ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF THE VIDAS® B.R.A.H.M.S PCT REF.30450-01 LOT 1008544030 TO ITS SPECIFICATION.

Description of Event or Problem

INTENTED 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 22-JUN-2021, A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OUT OF RANGE LOW WHEN TESTING VIDAS® BRAHMS PROCALCITONIN 60T (REF. 30450-01, LOT #1008544030, EXPIRY DATE: 25-JUL-2021) IN CONTEXT OF PROFICIENCY SAMPLE ASSAY. THE CUSTOMER TESTED THREE PROCALCITONIN CAP SURVEY SAMPLES. AMONG THEM, ONE SAMPLE FAILED, PCA-01, WHICH GAVE AS RESULT < 0.5 WHEREAS THE EXPECTED RANGE RESULT WAS [2.74 - 4.52]. CALIBRATION WAS DONE THE (B)(6) 2021 AND WAS VALID. THE SAMPLES WERE RUN ON SAME DAY AS CALIBRATION. THE CLIENT SPECIFIED THAT THE THREE SAMPLE TESTS WERE PERFORMED BY THREE DIFFERENT TECHNICIANS. THE CLIENT MENTIONED THAT IT WAS POSSIBLE THAT THE PROFICIENCY SAMPLE THAT FAILED COULD BE MADE UP WITH SALINE SOLUTION INSTEAD OF WATER. ACCORDING TO THE CUSTOMER 'S REPORT, THE QC SAMPLES WERE TESTED USING A MANUAL PIPETTING AND IT CAN BE SEEN THAT THE SIGNAL IS VERY LOW CLOSE TO ZERO (1RFV) THIS COULD INDICATE THAT THERE WAS NO PCT IN THE SAMPLE DISPENSED. ALSO TO BE NOTED, BIOMÉRIEUX LABORATORY SUBSCRIBED TO THE CAP PROGRAM AND WAS INVOLVED IN THE CHALLENGE PCT-A 2021, AND THE RESULTS WERE WITHIN THE EXPECTED RANGE FOR THE THREE CAP SURVEYS. AS THIS WAS A QUALITY CONTROL TEST, NO PATIENT SAMPLE WAS INVOLVED. THERE IS NO ADVERSE PATIENT IMPACT DUE TO THE DISCREPANT RESULT. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.