BD FACSLYRIC¿

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD BD FACSLYRIC¿ FLOW CYTOMETER EXPERIENCED CARRYOVER OF PATIENT SAMPLE. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT'S BLOOD WAS NOT COMPLETELY REMOVED AFTER THE SIT FLUSH. LAST WEEK'S VISIT WAS UNSUCCESSFUL. ANOTHER VISIT IS REQUIRED TO RESOLVE THE ISSUE." "MDR SAFETY CHECKLIST - CONTAMINATION. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/ MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED: CARRYOVER BETWEEN PATIENT SAMPLES. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: THE CONTAMINATION WAS DETECTED DIRECTLY BY THE PERSONNEL, SO NO WRONG RESULTS WERE REPORTED TO THE DOCTOR."

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.

Additional Manufacturer Narrative

THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX G: G04135. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF CARRYOVER WAS CONFIRMED. THE POTENTIAL CAUSE WAS DETERMINED TO BE THE V8 PINCH VALVE. THE FSE INVESTIGATED THE ISSUE AND REPLACED THE VALVE, WHICH RESOLVED THE ISSUE AND RETURNED THE INSTRUMENT TO OPERATIONAL STATUS. THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT AND NO USER OR PATIENT WAS HARMED OR INJURED. THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. REVIEW OF THE DHR CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER EXPERIENCED CARRYOVER OF PATIENT SAMPLE. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "THE PATIENT'S BLOOD WAS NOT COMPLETELY REMOVED AFTER THE SIT FLUSH. LAST WEEK'S VISIT WAS UNSUCCESSFUL. ANOTHER VISIT IS REQUIRED TO RESOLVE THE ISSUE." "MDR SAFETY CHECKLIST -- CONTAMINATION WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED: CARRYOVER BETWEEN PATIENT SAMPLES PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: THE CONTAMINATION WAS DETECTED DIRECTLY BY THE PERSONNEL, SO NO WRONG RESULTS WERE REPORTED TO THE DOCTOR".