BD FACSLYRIC¿

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBTAINED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT INTERMITTENTLY SOME SAMPLES SHOW A NON EXPECTED OUTCOME WHERE THE LYMPHOCYTE POPULATIONS DOES NOT SHOW B- OR T-CELL POPULATIONS. ONLY SEPARATE SAMPLES IN A RUN WOULD SHOW THIS OUTCOME AND OTHER SAMPLES ARE FINE. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO SAMPLES REDRAWN. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED.) NO.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - (B)(6). G.1 - REPORTING OFFICE AND MANUFACTURING SITE CONTACT - (B)(6). H.6 INVESTIGATION SUMMARY: BASED ON REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE MAX ACTIVITY, THE COMPLAINT WAS CONFIRMED AND THE POTENTIAL CAUSE OF THE CUSTOMER EXPERIENCING ERRONEOUS RESULTS ON THE FACSLYRIC WAS DETERMINED TO AUTOSCALING BEING TURNED ON. APPS SPECIALIST PERFORMED CHECKS AND ONCE AUTOSCALING WAS TURNED OFF THE DISTRIBUTION RETURNED TO NORMAL. THE INSTRUMENT IS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. 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.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. 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 ERRONEOUS RESULTS WERE OBTAINED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT INTERMITTENTLY SOME SAMPLES SHOW A NON EXPECTED OUTCOME WHERE THE LYMPHOCYTE POPULATIONS DOES NOT SHOW B- OR T-CELL POPULATIONS. ONLY SEPARATE SAMPLES IN A RUN WOULD SHOW THIS OUTCOME AND OTHER SAMPLES ARE FINE. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO SAMPLES REDRAWN. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED.) NO.