BD FACSCANTO¿ II

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 WHILE USING BD FACSCANTO¿ II CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX CALLED REPORTING A CARRYOVER PROBLEM WITH THIS INSTRUMENT. CARRYOVER NOTICED ON A 2 SAMPLE RUN. IT WAS CAUGHT. NO FALSE REPORTING BASED ON THIS CARRYOVER.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX CALLED REPORTING A CARRYOVER PROBLEM WITH THIS INSTRUMENT. -CARRYOVER NOTICED ON A 2 SAMPLE RUN. IT WAS CAUGHT. NO FALSE REPORTING BASED ON THIS CARRYOVER.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING CARRYOVER LINKED TO THE CLOGGED TUBING IN THE FLUIDIC SYSTEM. NO PARTS WERE REPLACED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. 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.