BD FACSCANTO¿ II FLOW CYTOMETER

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 FLOW CYTOMETER ABNORMAL RESULTS WERE OBTAINED. NO PATIENT INJURY OR DELAY IN TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "CUSTOMER REPORTED 2 OF THEIR INSTRUMENTS ARE GIVING AN ABNORMAL RESULT."

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF ABNORMAL RESULTS WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: MANUFACTURING, DEFECT, AND COMPLAINT TRENDS WERE REVIEWED. A RETURN SAMPLE WAS NOT REQUESTED BECAUSE NO PARTS WERE REPLACED. REGARDING POTENTIAL CAUSE AND RESOLUTION, THE FSE COMPLETED AN OPERATIONAL FUNCTIONAL CHECK AND A SYSTEM VERIFICATION AND WAS UNABLE TO REPRODUCE THE ISSUE. ALL SYSTEMS AND READINGS OF SIGNALS AND RESULTS MET BD SPECIFICATIONS. ALL SIGNALS AND CRITERIA FOR QC PASSED UPON COMPLETION OF THE SERVICE VISIT. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE ANY PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ II FLOW CYTOMETER ABNORMAL RESULTS WERE OBTAINED. NO PATIENT INJURY OR DELAY IN TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "CUSTOMER REPORTED 2 OF THEIR INSTRUMENTS ARE GIVING AN ABNORMAL RESULT".