BD FACSLYRIC¿

Additional Manufacturer Narrative

H.6 SCOPE OF ISSUE: THE SCOPE OF THE ISSUE IS LIMITED TO PART 659180 FACSLYRIC 3L10C INSTRUMENT AND: INSTRUMENT: (B)(6), SOFTWARE VERSION: V1.5. PROBLEM STATEMENT: THE CUSTOMER REPORTED COMPLAINT ON 22ND SEP 2023 THAT WRONG VALUES WERE REPORTED IN THE PDF FILE. THE CUSTOMER (B)(6) OBSERVED THAT WHEN ACQUISITION OF LARGE AMOUNT OF DATA AND/OR WHEN USE OF VERY BIG TEMPLATES, AND DURING RE-GATING IS IN PROGRESS IT WAS POSSIBLE FOR THEM TO APPROVE WHILE THE SOFTWARE HAS NOT FINISHED CALCULATIONS CAUSING WRONG VALUES TO BE REPORTED IN PDF REPORTS TO CLINICIANS. INVESTIGATION SUMMARY: COMPLAINT HISTORY REVIEW: THERE ARE 2 COMPLAINTS RELATED TO THE REPORTED COMPLAINTS FROM 22SEP2022 TO DATE 22SEP2023 RELATED COMPLAINT NUMBER(S): (B)(4). REFERENCE AZURE OR EDMS DEFECT#: AZURE DEFECT BUG 419223:( (B)(4) ERRONEOUS RESULT FROM FACSUITE V1.5 SOFTWARE REPORTED TO THE CLINICIANS) WAS INITIATED TO ADDRESS THE REPORTED ISSUE ON THE SOFTWARE. RETURNED SAMPLE ANALYSIS: THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE REQUIRED INFORMATION WAS PROVIDED. THE PROVIDED INFORMATION WAS EVALUATED, AND THE RESULT WAS THAT THE ISSUE IS CONFIRMED. BASED ON THE EVALUATION IT IS CONFIRMED THAT THE ISSUE WAS RELATED TO THE ABOVE BUG. RISK REVIEW: RISK MANAGEMENT FILE PART # 10000063058RA, RISK ANALYSIS FACSLYRIC IVD, REV. 8 WAS REVIEWED. HAZARD(S) IDENTIFIED? NO IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? - UPDATE RISK DOCUMENT THROUGH ECR # (B)(4) HAS BEEN INITIATED TO ADD THE DEFECT RELATED TO THIS ISSUE. POTENTIAL CAUSE: BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL CAUSE WAS DETERMINED TO BE USER CLICKING APPROVE BUTTON WHILE RECALCULATION IS STILL IN PROGRESS ON RE-GATING WHEN ACQUISITION OF LARGE AMOUNT OF DATA. WHILE THE SYSTEM IS IN THE PROCESS OF CALCULATING RESULTS, THERE WILL BE A WAIT CURSOR. USER SHOULD WAIT UNTIL THE CURSOR DISAPPEARS AND THEN CLICK ON APPROVE BUTTONS TO AVOID THE ISSUE OBSERVED. THE ISSUE WAS ALSO NOT OBSERVED WHEN THE CUSTOMER UPGRADED THEIR SYSTEM FROM Z240 TO Z2 MINI G5. DETAILED ROOT CAUSE HAS BEEN ADDED TO THE AZURE DEFECT 419223. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, THE POTENTIAL CAUSE OF THE ISSUE OF WRONG VALUES WERE REPORTED IN THE PDF FILE WHEN ACQUISITION OF LARGE AMOUNT OF DATA AND/OR WHEN USE OF VERY BIG TEMPLATES WAS DUE TO USER CLICKING APPROVE BUTTON WHILE RECALCULATION IS STILL IN PROGRESS ON RE-GATING WHEN ACQUISITION OF LARGE AMOUNT OF DATA. WHILE THE SYSTEM IS IN THE PROCESS OF CALCULATING RESULTS, THERE WILL BE A WAIT CURSOR. USER SHOULD WAIT UNTIL THE CURSOR DISAPPEARS AND THEN CLICK ON APPROVE BUTTONS TO AVOID THE ISSUE OBSERVED. THE ERRONEOUS RESULT WAS NOT OBVIOUS AT FIRST BUT WHEN THE USER DOUBLE CHECKED IT, IT WAS OBVIOUS THERE WAS PATIENT SAMPLE INVOLVED AND ERRONEOUS RESULT REPORTED TO THE CLINICIAN. THOUGH ERRONEOUS RESULT WAS REPORTED, PATIENT WAS NOT TREATED BASED ON THE ERRONEOUS RESULT. THE PROBLEM WAS DISCOVERED BEFORE TREATMENT WAS ISSUED. THE PROVIDED DATA WAS EVALUATED AND IT WAS DETERMINED THAT THE ISSUE WAS CONFIRMED. AZURE DEFECT 419223 WAS INITIATED. USER SHOULD WAIT UNTIL THE CURSOR DISAPPEARS AND THEN CLICK ON APPROVE BUTTONS TO AVOID THE ISSUE OBSERVED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, COMPLAINT WAS CONFIRMED. DEFECT BUG HAS BEEN CREATED FOR THE ISSUE. IT WILL BE PRIORITIZED AND FIXED IN THE LATER FACSUITE RELEASE 1.6.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS WRONG RESULTS DISPLAYED ON PDF REPORT. ON ACQUISITIONS WITH LARGE AMOUNT OF DATA AND/OR THE USE OF VERY BIG TEMPLATES, WHEN RE-GATING, IT IS POSSIBLE TO PRESS APPROVE WHILE THE SOFTWARE HAS NOT FINISHED CALCULATIONS. THIS GIVES PDF'S WITH WRONG NUMBERS. THE FCS FILES ARE OK. WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? NOT AT FIRST, BUT WHEN THE USER DOUBLECHECKED IT, IT WAS OBVIOUS WERE PATIENT SAMPLES INVOLVED? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? YES. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? THE PROBLEM WAS DISCOVERED BEFORE TREATMENT WAS ISSUED.

Additional Manufacturer Narrative

D4: MEDICAL DEVICE EXPIRATION DATE: NA. H3: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS WRONG RESULTS DISPLAYED ON PDF REPORT. ON ACQUISITIONS WITH LARGE AMOUNT OF DATA AND/OR THE USE OF VERY BIG TEMPLATES, WHEN RE-GATING, IT IS POSSIBLE TO PRESS APPROVE WHILE THE SOFTWARE HAS NOT FINISHED CALCULATIONS. THIS GIVES PDF'S WITH WRONG NUMBERS. THE FCS FILES ARE OK. WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? NOT AT FIRST, BUT WHEN THE USER COUNTERCHECKED IT, IT WAS OBVIOUS. WERE PATIENT SAMPLES INVOLVED? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? YES. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? THE PROBLEM WAS DISCOVERED BEFORE TREATMENT WAS ISSUED.