BD FACSLYRIC¿

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED INVOLVING 20-30 PATIENT SAMPLES. CONFIRMATION OF THE NUMBER OF PATIENT SAMPLES INVOLVED WAS UNABLE TO BE OBTAINED. THERE WAS NO PATIENT IMPACT AS SAMPLES WERE RAN ON A BACKUP INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT DURING SAMPLE MEASUREMENTS THEY NOTICE THAT THERE IS UNEXPECTED SIGNAL IN THE SSC CHANNEL - UP TO 10% WHICH IS A LOT. THEY ARE SUSPECTING CARRYOVER FROM OTHER SAMPLES. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN. GO TO QUESTION #2 CARRYOVER BETWEEN PATIENT SAMPLES.

Additional Manufacturer Narrative

H.6 INVESTIGATION EXEC SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF CONTAMINATION - CARRY OVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: PERFORMED ALSO CLEANING AND FLUSHING OF THE SYSTEM, REPLACING THE SAMPLE LINE, REPLACING THE FLOW CELL RESTRICTOR AND INFORMED THE TECHNICIAN(S) TO PERFORM ADDITIONAL SIT FLUSHES. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. POTENTIAL CAUSE WAS DUE TO A WORN WASTE CHECK VALVE. THE ISSUE WAS RESOLVED BY REPLACEMENT OF THE WASTE CHECK VALVE. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.

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¿ FLOW CYTOMETER CARRYOVER INVOLVING PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT DURING SAMPLE MEASUREMENTS THEY NOTICE THAT THERE IS UNEXPECTED SIGNAL IN THE SSC CHANNEL - UP TO 10% WHICH IS A LOT. THEY ARE SUSPECTING CARRYOVER FROM OTHER SAMPLES. 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN ¿ GO TO QUESTION #2. CARRYOVER BETWEEN PATIENT SAMPLES.

Additional Manufacturer Narrative

THE FOLLOWING FIELD WAS UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM:. IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED INVOLVING 20-30 PATIENT SAMPLES. CONFIRMATION OF THE NUMBER OF PATIENT SAMPLES INVOLVED WAS UNABLE TO BE OBTAINED. THERE WAS NO PATIENT IMPACT AS SAMPLES WERE RAN ON A BACKUP INSTRUMENT.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED INVOLVING 20-30 PATIENT SAMPLES. CONFIRMATION OF THE NUMBER OF PATIENT SAMPLES INVOLVED WAS UNABLE TO BE OBTAINED. THERE WAS NO PATIENT IMPACT AS SAMPLES WERE RAN ON A BACKUP INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT DURING SAMPLE MEASUREMENTS THEY NOTICE THAT THERE IS UNEXPECTED SIGNAL IN THE SSC CHANNEL - UP TO 10% WHICH IS A LOT. THEY ARE SUSPECTING CARRYOVER FROM OTHER SAMPLES. 1.WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN ¿ GO TO QUESTION #2.:CARRYOVER BETWEEN PATIENT SAMPLES.