FACSCANTO

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT WAS CONFIRMED, AND THE CAUSE OF THE COMPLAINT WAS A FAULTY BLUE LASER FIBER. THE CUSTOMER HAD REPORTED THAT THEY OBSERVED ERRONEOUS RESULTS, AND AN FSE WAS SENT ONSITE TO OBSERVE THE ISSUE. THE FSE INSPECTED THE MACHINE, FOUND THAT THE BLUE FIBER ATTENUATION WAS AGING, AND REPLACED THE FIBER. THE INSTRUMENT WAS THEN TESTED AND CONFIRMED TO BE TESTING PER BD SPECIFICATIONS. THERE WAS NO IMPACT TO CUSTOMER OR PATIENT SAFETY DUE TO THIS EVENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED WITHOUT REQUIRING A SAMPLE ANALYSIS. 2 COMPLAINTS REGARDING SIMILAR ISSUES REGARDING UNEXPECTED RESULTS DUE TO FIBERS WERE IDENTIFIED WITHIN 12 MONTHS OF THIS EVENT INCLUDING THIS ONE. DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED AS THE ROOT CAUSE WAS IDENTIFIED IN THE FIELD.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ FLOW CYTOMETER PRODUCED ERRONEOUS FINAL LABORATORY RESULT FROM THE BD PRODUCT THAT WAS REPORTED TO A CLINICIAN. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FACSCANTO PLUS-UNSATISFACTORY SAMPLE RESULTS USING PATIENT SAMPLES, NOT SURE IF IT CAUSES HARM." MDR SAFETY CHECKLIST FOR PATIENT SAMPLES. 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. - YES. 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. - YES. MDR SAFETY CHECKLIST FOR CONTAMINATION. 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.: NO.

Additional Manufacturer Narrative

D.4: MEDICAL DEVICE EXPIRATION DATE: NA. E.1: (B)(6). E.1: (B)(6). 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¿ FLOW CYTOMETER PRODUCED ERRONEOUS FINAL LABORATORY RESULT FROM THE BD PRODUCT THAT WAS REPORTED TO A CLINICIAN. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FACSCANTO PLUS-UNSATISFACTORY SAMPLE RESULTS USING PATIENT SAMPLES, NOT SURE IF IT CAUSES HARM". MDR SAFETY CHECKLIST FOR PATIENT SAMPLES. 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. - YES. 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. - YES. MDR SAFETY CHECKLIST FOR CONTAMINATION. 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.: NO.