BD FACS¿ SAMPLE PREP ASSISTANT III

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 FACS¿ SAMPLE PREP ASSISTANT III THE CUSTOMER REPORTED ERRONEOUS RESULTS THAT WERE REPORTED TO A CLINICIAN. 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: COMPLAINT TREND, MANUFACTURING DEFECT TREND, RISK REVIEW. THE POTENTIAL CAUSE WAS NOT DETERMINED AS THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPRODUCE THE ISSUE AND NOTED IN THE WORK ORDER NOTES THAT THE INSTRUMENT PASSED ALL TESTS WITH OPERATIONAL ACCURACY AND PERFORMANCE. WHILE RESULTS WERE REPORTED TO THE CLINICIAN THERE WAS NO DELAY OF TREATMENT, HARM, OR INJURY AS A RESULT OF THIS ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III THE CUSTOMER REPORTED ERRONEOUS RESULTS THAT WERE REPORTED TO A CLINICIAN. NO PATIENT INJURY OR DELAY IN TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED 2 OF THEIR INSTRUMENT ARE GIVING AN ABNORMAL RESULT".