BD FACSLYRIC¿ 3L10C INSTRUMENT

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ 3L10C INSTRUMENT ERRONEOUS CD34 RESULTS WERE OBTAINED AND REPORTED TO CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A STEM CELL PRODUCT WAS STAINED, RUN, ANALYZED AND GATED WITHOUT ISSUE AND WITHOUT ANY ALTERATION TO THE HIERARCHY, EXPRESSIONS, OR TRUCOUNT ON BUCKS. HOWEVER, THE RESULTS PRODUCED FOR THE TOTAL CD34 COUNT AND %VIABILITY WERE ERRONEOUS FOR NO REASON THAT I CAN DETERMINE ¿ SPECIFICALLY, THE CD34 TOTAL WAS LESS THAN IT ACTUALLY WAS AND LESS THAN THE VIABLE CD34, AND THE RESULTANT %VIABILITY WAS >100%. ADDITIONAL INFORMATION OBTAINED FROM CUSTOMER: IT IS NOT ROUTINE PRACTICE FOR OUR STAFF TO INSPECT THE FULL LIST OF NUMBERS FOR THIS ASSAY, SINCE WE VALIDATED RESULT TRANSMISSION EXTENSIVELY, SO THE RESULTS WERE REPORTED WHICH WAS THEN FOLLOWED BY A CLINIC STAFF CALLING TO ASK WHAT WAS WRONG WITH OUR NUMBERS. TESTING WAS REPEATED ON STAR AND RESULTS WERE AMENDED FOR THE PATIENT, BUT INTERESTINGLY WHEN THE STAFF WENT BACK TO THE WORKLIST ON BUCKS, THEY CLOSED AND REOPENED THE WORKLIST WHICH MAGICALLY CORRECTED THE NUMBERS FROM THE ORIGINAL RUN WITH NO OTHER CHANGES BEING MADE. I HAVE ATTACHED THE PDFS FROM BOTH THE PRE WORKLIST CLOSURE AND POST WORKLIST CLOSURE.

Additional Manufacturer Narrative

G.5. THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: H6: IMDRF ANNEX B: B21; H6: IMDRF ANNEX C: C21; H6: IMDRF ANNEX D: D16.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ 3L10C INSTRUMENT ERRONEOUS CD34 RESULTS WERE OBTAINED AND REPORTED TO CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A STEM CELL PRODUCT WAS STAINED, RUN, ANALYZED AND GATED WITHOUT ISSUE AND WITHOUT ANY ALTERATION TO THE HIERARCHY, EXPRESSIONS, OR TRUCOUNT ON BUCKS. HOWEVER, THE RESULTS PRODUCED FOR THE TOTAL CD34 COUNT AND %VIABILITY WERE ERRONEOUS FOR NO REASON THAT I CAN DETERMINE ¿ SPECIFICALLY, THE CD34 TOTAL WAS LESS THAN IT ACTUALLY WAS AND LESS THAN THE VIABLE CD34, AND THE RESULTANT %VIABILITY WAS >100%. ADDITIONAL INFORMATION OBTAINED FROM CUSTOMER: IT IS NOT ROUTINE PRACTICE FOR OUR STAFF TO INSPECT THE FULL LIST OF NUMBERS FOR THIS ASSAY, SINCE WE VALIDATED RESULT TRANSMISSION EXTENSIVELY, SO THE RESULTS WERE REPORTED WHICH WAS THEN FOLLOWED BY A CLINIC STAFF CALLING TO ASK WHAT WAS WRONG WITH OUR NUMBERS. TESTING WAS REPEATED ON STAR AND RESULTS WERE AMENDED FOR THE PATIENT, BUT INTERESTINGLY WHEN THE STAFF WENT BACK TO THE WORKLIST ON BUCKS, THEY CLOSED AND REOPENED THE WORKLIST WHICH MAGICALLY CORRECTED THE NUMBERS FROM THE ORIGINAL RUN WITH NO OTHER CHANGES BEING MADE. I HAVE ATTACHED THE PDFS FROM BOTH THE PRE-WORKLIST CLOSURE AND POST WORKLIST CLOSURE.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE RESULTS PRODUCED FOR THE TOTAL CD34 COUNT AND %VIABILITY WERE ERRONEOUS WAS CONFIRMED. THE PROVIDED INFORMATION INCLUDING SYSTEM LOGS, ASSAY, FCS FILES AND PDF FILES WERE EVALUATED. THE POTENTIAL CAUSE WAS THAT THE REPORT WAS GENERATED WHILE THE COMPUTATION WAS STILL IN PROGRESS. INVESTIGATION SHOWED THAT WHILE THE SYSTEM WAS IN THE PROCESS OF CALCULATING RESULTS, THE REPORTS WERE GENERATED. A DEFECT WAS RAISED AND WILL BE PRIORITIZED AND FIXED IN THE LATER FACSUITE RELEASE.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ 3L10C INSTRUMENT ERRONEOUS CD34 RESULTS WERE OBTAINED AND REPORTED TO CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A STEM CELL PRODUCT WAS STAINED, RUN, ANALYZED AND GATED WITHOUT ISSUE AND WITHOUT ANY ALTERATION TO THE HIERARCHY, EXPRESSIONS, OR TRUCOUNT ON BUCKS. HOWEVER, THE RESULTS PRODUCED FOR THE TOTAL CD34 COUNT AND %VIABILITY WERE ERRONEOUS FOR NO REASON THAT I CAN DETERMINE ¿ SPECIFICALLY, THE CD34 TOTAL WAS LESS THAN IT ACTUALLY WAS AND LESS THAN THE VIABLE CD34, AND THE RESULTANT %VIABILITY WAS >100%. ADDITIONAL INFORMATION OBTAINED FROM CUSTOMER: IT IS NOT ROUTINE PRACTICE FOR OUR STAFF TO INSPECT THE FULL LIST OF NUMBERS FOR THIS ASSAY, SINCE WE VALIDATED RESULT TRANSMISSION EXTENSIVELY, SO THE RESULTS WERE REPORTED WHICH WAS THEN FOLLOWED BY A CLINIC STAFF CALLING TO ASK WHAT WAS WRONG WITH OUR NUMBERS. TESTING WAS REPEATED ON STAR AND RESULTS WERE AMENDED FOR THE PATIENT, BUT INTERESTINGLY WHEN THE STAFF WENT BACK TO THE WORKLIST ON BUCKS, THEY CLOSED AND REOPENED THE WORKLIST WHICH MAGICALLY CORRECTED THE NUMBERS FROM THE ORIGINAL RUN WITH NO OTHER CHANGES BEING MADE. I HAVE ATTACHED THE PDFS FROM BOTH THE PRE-WORKLIST CLOSURE AND POST WORKLIST CLOSURE.