BD FACSLYRIC¿

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4 MEDICAL DEVICE CATALOG #: 659180. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.4. MEDICAL DEVICE SERIAL#: (B)(6). H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE WHERE LOSS OF FCS IN WORKLIST USING PCST ASSAY IN FACSUITE CLINICAL. THE PROVIDED INFORMATION INCLUDING SYSTEM LOGS, WORKLIST FILE WERE EVALUATED. THE POTENTIAL CAUSE COULD NOT BE DETERMINED BECAUSE THE PROVIDED DATA WAS INSUFFICIENT FOR INVESTIGATION AND ADDITIONAL REQUESTED DATA WAS NOT RECEIVED FROM THE CUSTOMER. A DEFECT WAS RAISED AND WILL BE CLOSED AS NOT REPRODUCIBLE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿, A SOFTWARE ERROR RESULTED IN IRRETRIEVABLE PATIENT DATA LOSS. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER ACQUIRED A BONE MARROW SAMPLE STAINED WITH ONE FLOW PCST PRODUCT IN ONE FLOW PCST ASSAY IN SUITE CLINICAL SOFTWARE. AFTER THE ACQUISITION (SAMPLE WITH HIGH NUMBER OF EVENTS), THE FILE WAS MISSING. THE CUSTOMER PREPARED AGAIN THE SAMPLE AND TRIED TO ACQUIRE THE SAMPLE AGAIN IN THE SAME POSITION OF THE WORKLIST. AT THE END THE FILE WAS MISSING AGAIN AND WHEN HE TRIED TO SELECT THE TUBE, IT APPEARED A MESSAGE IT'S NOT POSSIBLE TO OPEN THE FILE BECAUSE THE WORKLIST IS CORRUPTED THE CUSTOMER OPENED ANOTHER WORKLIST AND ACQUIRED SUCCESSFULLY THE REMAINING SAMPLE¿. MDR SAFETY - PATIENT SAMPLES CHECKLIST, REFER TO ATTACHMENT "RE CLARIFICATION REQUEST - (B)(4)": 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED: NO. COULD YOU PLEASE ANSWER THE FOLLOWING CHECKLIST REGARDING THE LYRIC SOFTWARE? 1. ARE YOU PERFORMING DIAGNOSTIC TESTS ON PATIENT SAMPLES? YES. 2. DID A SOFTWARE ERROR CAUSE IRREVERSIBLE LEAKAGE OF PATIENT DATA? YES, TWICE. 3. DID THE LOSS OF PATIENT DATA RESULT IN THE NEED TO REPEAT TESTING ON PATIENT SAMPLES? YES, AND IT WAS ONLY POSSIBLE BECAUSE THE CUSTOMER STILL HAD BONE MARROW TO STAIN. 4. DID THE PROBLEM CAUSE DELAYS IN TREATMENT? NO, ONLY BECAUSE THE CUSTOMER STILL HAD BONE MARROW TO STAIN."

Additional Manufacturer Narrative

H.3. 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 WHILE USING BD FACSLYRIC¿, A SOFTWARE ERROR RESULTED IN IRRETRIEVABLE PATIENT DATA LOSS. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER ACQUIRED A BONE MARROW SAMPLE STAINED WITH ONE FLOW PCST PRODUCT IN ONE FLOW PCST ASSAY IN SUITE CLINICAL SOFTWARE. AFTER THE ACQUISITION (SAMPLE WITH HIGH NUMBER OF EVENTS), THE FILE WAS MISSING. THE CUSTOMER PREPARED AGAIN THE SAMPLE AND TRIED TO ACQUIRE THE SAMPLE AGAIN IN THE SAME POSITION OF THE WORKLIST. AT THE END THE FILE WAS MISSING AGAIN AND WHEN HE TRIED TO SELECT THE TUBE, IT APPEARED A MESSAGE IT'S NOT POSSIBLE TO OPEN THE FILE BECAUSE THE WORKLIST IS CORRUPTED THE CUSTOMER OPENED ANOTHER WORKLIST AND ACQUIRED SUCCESSFULLY THE REMAINING SAMPLE¿. MDR SAFETY - PATIENT SAMPLES CHECKLIST: DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED: NO. COULD YOU PLEASE ANSWER THE FOLLOWING CHECKLIST REGARDING THE LYRIC SOFTWARE? ARE YOU PERFORMING DIAGNOSTIC TESTS ON PATIENT SAMPLES? YES. DID A SOFTWARE ERROR CAUSE IRREVERSIBLE LEAKAGE OF PATIENT DATA? YES, TWICE. DID THE LOSS OF PATIENT DATA RESULT IN THE NEED TO REPEAT TESTING ON PATIENT SAMPLES? YES, AND IT WAS ONLY POSSIBLE BECAUSE THE CUSTOMER STILL HAD BONE MARROW TO STAIN. DID THE PROBLEM CAUSE DELAYS IN TREATMENT? NO, ONLY BECAUSE THE CUSTOMER STILL HAD BONE MARROW TO STAIN.".