BD FACSLYRIC¿

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. CALLED AND SPOKE WITH CUSTOMER AND CUSTOMER STATED THAT THEY WERE PATIENT SAMPLES BUT THEY DETECTED THE ISSUE RIGHT AWAY AND STOPPED USING THIS LYRIC. NO FALSE RESULTS WERE REPORTED TO PATIENTS OR DOCTORS AS A RESULT OF THIS ISSUE. IT WAS REPORTED BY THE CUSTOMER THAT CARRY OVER OF SAMPLES. SIT FLUSH MAY NOT BE FUNCTIONING PROPERLY. NO FALSE RESOLVES WERE REPORTED TO PATIENTS OR DOCTORS.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. G.5. PMA / 510(K)#: K170974 G.5. PMA / 510(K)#: K201814. 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 CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE CHECKLIST: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. CALLED AND SPOKE WITH CUSTOMER AND CUSTOMER STATED THAT THEY WERE PATIENT SAMPLES BUT THEY DETECTED THE ISSUE RIGHT AWAY AND STOPPED USING THIS LYRIC. NO FALSE RESULTS WERE REPORTED TO PATIENTS OR DOCTORS AS A RESULT OF THIS ISSUE. IT WAS REPORTED BY THE CUSTOMER THAT CARRY OVER OF SAMPLES. SIT FLUSH MAY NOT BE FUNCTIONING PROPERLY. NO FALSE RESOLVES WERE REPORTED TO PATIENTS OR DOCTORS.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED: G.1. REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES. G.2. REPORTING OFFICE CONTACT: (B)(6) - MDR. G.4. MANUFACTURING SITE CONTACT: (B)(6) - MDR. H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT WAS CONFIRMED AND THE POTENTIAL CAUSE OF THE CUSTOMER EXPERIENCING CARRYOVER ISSUES ON THE FACSLYRIC WAS DETERMINED TO BE PLUGGED SIT ASSEMBLY. FSE PERFORMED SYSTEM CHECKS INCLUDING A SIT FLUSH, P2 AND V8 ASSEMBLY. FSE THEN REMOVED AND CLEANED& FLUSHED THE SIT ASSEMBLY. AFTERWARDS, 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 WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED TO DETERMINE IF FURTHER ACTION IS NEEDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.