BD FACS¿ LYSE WASH ASSISTANT

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS LYSE WASH ASSISTANT CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THIS HAS OCCURRED 2 TIMES IN THE LAST YEAR AND NO PATIENT IMPACT WAS REPORTED . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES IT WAS REPORTED BY THE CUSTOMER THAT SAMPLE CARRY-OVER ISSUE.

Additional Manufacturer Narrative

B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT DURING USE WITH BD FACS LYSE WASH ASSISTANT CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THIS HAS OCCURRED 2 TIMES IN THE LAST YEAR AND NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES IT WAS REPORTED BY THE CUSTOMER THAT SAMPLE CARRY-OVER ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS LYSE WASH ASSISTANT CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES. IT WAS REPORTED BY THE CUSTOMER THAT SAMPLE CARRY-OVER ISSUE.

Additional Manufacturer Narrative

H.3. BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF SAMPLE CARRYOVER WAS NOT CONFIRMED AND THE POTENTIAL CAUSE COULD NOT BE DETERMINED. THE FSE INVESTIGATED THE ISSUE AND PERFORMED PM ACTIVITIES, BUT COULD NOT REPRODUCE THE ERROR OR CONFIRM THE CARRYOVER ISSUE, AND THE INSTRUMENT WAS RETURNED TO OPERATIONAL STATUS. THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT AND NO USER OR PATIENT WAS HARMED OR INJURED. THE CUSTOMER WAS ADVISED TO CALL APPLICATIONS FOR GUIDANCE ON PROTOCOL SETUPS AND WILL CALL BACK IF ISSUE OCCURS AGAIN. THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE NO PARTS WERE REPLACED. REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. 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

H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS LYSE WASH ASSISTANT CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES IT WAS REPORTED BY THE CUSTOMER THAT SAMPLE CARRY-OVER ISSUE.