VIDAS ANALYSER

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE UNITED STATES REGARDING A QCV FAILURE OCCURRING IN POSITION B1 WHEN USING THE VIDAS® ANALYSER INSTRUMENT (REF. 99735, SERIAL (B)(6)). THE RETROSPECTIVE ANALYSIS PERFORMED SHOWED AN IMPACT ON VIDAS® B·R·A·H·M·S PCT¿ (PROCALCITONIN) TEST RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER¿S SITE IN ORDER TO REPAIR AND QUALIFY THE INSTRUMENT. FSE INVESTIGATED THE CUSTOMER¿S ISSUE AND PERFORMED SEVERAL ACTIONS ACCORDING TO MAR 1901. NO ANOMALIES WERE DETECTED. THE VIDAS® ANALYSER SYSTEM WAS OPERATING PER MANUFACTURING SPECIFICATIONS. A QCV FAILURE IS NOT AN ABNORMAL BEHAVIOR; IT MEANS THAT THE QCV PLAYED ITS ROLE AS A FUNCTIONAL CONTROL. THIS CONTROL IS MEANT TO DETECT RESIDUAL RISKS THAT ARE RARE AND SUDDEN. RESIDUAL RISKS ARE ALREADY PRESENT AND ACCEPTED INTO THE SYSTEM RISK ANALYSIS. THE ROOT CAUSE OF THE QCV FAILURE WAS A CLOG BEGINNING TO FORM IN THE PUMPS. FSE PERFORMED A PUMP CHANNEL CLEANING AND REPLACED THE PUMP SEALS AFTER A VISUAL INSPECTION WAS PERFORMED.SEE SECTION H10.

Description of Event or Problem

A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A QCV FAILURE OCCURRING IN POSITION B1 WHEN USING THE VIDAS® ANALYSER INSTRUMENT (REF. 99735, SERIAL (B)(4) ). THE RETROSPECTIVE ANALYSIS PERFORMED SHOWED AN IMPACT ON VIDAS® B·R·A·H·M·S PCT¿ (PROCALCITONIN) TEST RESULTS. THIS QCV FAILURE OCCURRED ON (B)(6) 2020. FSE INTERVENTION WAS PERFORMED ON (B)(6) 2020, AND THE ISSUE WAS RESOLVED BY A SEAL REPLACEMENT. THE LAST CONFORMING QCV WAS PERFORMED ON (B)(6) 2020. QCV FAILURE IS NOT A MALFUNCTION; HOWEVER, IT CAN BE ASSOCIATED WITH INCORRECT RESULTS (PRIOR TO QCV FAILURE). THEREFORE, BIOMÉRIEUX REQUESTS CUSTOMERS TO CONDUCT A RETROSPECTIVE ANALYSIS FROM THE LAST PASSED QCV UNTIL THE PRESENT QCV FAILURE. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS FOR SAMPLES RUN IN POSITION B1 OF THE VIDAS ANALYSER FROM THE (B)(6). DURING THE CONCERNED PERIOD OF TIME, FOR VIDAS PCT, 72 SAMPLES WERE RUN IN POSITION B1. IT WAS INDICATED THAT ONLY 26 OF THESE SAMPLES WERE RERAN IN RETROSPECTIVE ANALYSIS (OTHER SAMPLES WERE NOT AVAILABLE). FOR THESE 26 SAMPLES, THE RETROSPECTIVE REVIEW DETERMINED THAT THREE (3) SAMPLES HAD INITIAL UNDERESTIMATED RESULTS REGARDLESS OF THE RANGE OF EXPECTED VALUES FOR THE DIFFERENT INDICATIONS FOR USE FOR THE VIDAS PCT ASSAY (SEPSIS OR LTRI). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY INCORRECT TREATMENT OR ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.