NUCLISENS® LYSIS BUFFER

Description of Event or Problem

A CUSTOMER FROM THE (B)(6) REPORTED TO BIOMÉRIEUX A PRODUCT PERFORMANCE PROBLEM IN ASSOCIATION WITH NUCLISENS® LYSIS BUFFER. THE TEST ELUATES WERE COLORED FOR BLOOD SAMPLES. THE CUSTOMER TESTED THE COLORED ELUATES AND WAS NOT ABLE TO COMMUNICATE RESULTS BECAUSE THE SAMPLES WERE INHIBITED. THE CUSTOMER REPORTED THERE WAS A DELAY MORE THAN 48 HOURS IN OBTAINING RESULTS. NO RESULTS WERE REPORTED TO THE PHYSICIAN AND THERE WAS NO IMPACT TO PATIENTS OR THEIR TREATMENT. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

Additional Manufacturer Narrative

A CUSTOMER FROM THE (B)(6) REPORTED TO BIOMÉRIEUX A PROBLEM WITH DISCOLORATION OF TEST ELUATES FOR SEVERAL WHOLE BLOOD EXTRACTIONS IN ASSOCIATION WITH NUCLISENS® LYSIS BUFFER. AN INVESTIGATION WAS CONDUCTED. THE INVESTIGATION CONFIRMED THE CUSTOMER ISSUE. THE ELUATE BECOMES COLORED BECAUSE OF THE PRESENCE OF HEMOGLOBIN IN BLOOD SAMPLES. THE PRESENCE OF HEMOGLOBIN CAN CAUSE THE INHIBITION OF DOWNSTREAM APPLICATIONS (PCR, RT PCR, NASBA ETC.), RESULTING IN UNINTERPRETABLE TEST RESULTS. IF AN INTERNAL CONTROL IS USED, AS IT IS RECOMMENDED FOR MOLECULAR TESTS, IT WOULD BE INHIBITED THEREBY INVALIDATING THE TEST. IF THE INTERNAL CONTROL WOULD NOT BE INHIBITED OR NOT USED AT ALL, THE TESTS RUN WITH COLORED ELUATES COULD POTENTIALLY RESULT IN FALSE NEGATIVE RESULTS. THE ROOT CAUSE OF THE COLORATION HAS BEEN CONFIRMED TO BE LINKED TO A NON-CONFORMING PH VALUE FOR BATCH 16092902. IT HAS BEEN MEASURED AT 6.9 INSTEAD OF 7.1 +/ -0.1 AS PER PRODUCT SPECIFICATION. THE ORIGIN OF THE PH NON-CONFORMITY HAS BEEN IDENTIFIED AND ADDITIONAL TESTS AND PRECAUTIONS HAVE BEEN ALREADY PUT IN PLACE TO AVOID THIS ISSUE IN THE FUTURE. THE INVESTIGATION CONFIRMED THAT NO OTHER LOTS OF NUCLISENS® LYSIS BUFFER (REF (B)(4)), OR ANY OTHER NUCLISENS® EXTRACTION REAGENT AVAILABLE IN THE FIELD, HAVE BEEN IMPACTED BY THE SAME PH NON-CONFORMANCE. THE PH ISSUE WAS ALSO CHECKED FOR AN IMPACT ON OTHER MATRICES, EVEN IF THE INHIBITION IS DUE TO THE HEMOGLOBIN. DRY BLOOD SPOT (CONTAINING HEMOGLOBIN) AND STOOLS WERE TESTED WHICH CONFIRMED THE ISSUE CAN HAPPEN FOR THE DRY BLOOD SPOT BUT NOT FOR THE STOOLS. THE INVESTIGATION CONFIRMED THE CUSTOMER COMPLAINT AND CORRECTIVE AND PREVENTATIVE ACTIONS ARE BEING IMPLEMENTED INTO THE MANUFACTURING PROCESS. A FIELD SAFETY CORRECTIVE ACTION WAS ISSUED AS FSCA 3337- NUCLISENS LYSIS BUF - REF 200292_LOT 16092902_COLORED ELUATES EXHIBITING PCR INHIBITION PUBLISHED THE 08MAR2017.