BD FACSLYRIC¿

Additional Manufacturer Narrative

THE FOLLOWING FIELD HAS BEEN CORRECTED: H6: IMDRF ANNEX CODE A: A1801. H6: INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF SAMPLE CONTAMINATION WAS CONFIRMED. THE POTENTIAL CAUSE WAS DETERMINED TO BE SHEATH FILTER AND PINCH VALVE V8 FAILURE. THE FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE ISSUE AND REPLACED THESE COMPONENTS, WHICH RESOLVED THE ISSUE AND RETURNED THE INSTRUMENT TO OPERATIONAL STATUS. THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT AND NO USER OR PATIENT WAS HARMED OR INJURED. THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FOREIGN MATTER CONTAMINATION IMPACTED PATIENT RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "FSE INFORMS US THAT IT HAS BEEN INFORMED ABOUT THE CONTAMINATION DETECTED". ¿PATIENT SAMPLES CHECKLIST: 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. 3. WAS THERE ANY CHANGE OR DELAY OF TREATMENT DUE TO THE ISSUE? IF YES, GO TO QUESTION #4. IF NO, GO TO QUESTION #5. NO. 4. PLEASE DESCRIBE ANY ADDITIONAL DETAILS. GO TO QUESTION #5. 5. WAS THERE ANY PHYSICAL HARM/INJURY OR NEGATIVE IMPACT TO THE PATIENT DUE TO THE ISSUE? IF YES, GO TO QUESTION #6. IF NO, NO FURTHER QUESTIONS REQUIRED. NO. 6. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? GO TO QUESTION #7. 7. WHAT IS THE CURRENT MEDICAL STATUS? 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. PATIENT SAMPLES CONTAMINATED".

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FOREIGN MATTER CONTAMINATION IMPACTED PATIENT RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "FSE INFORMS US THAT IT HAS BEEN INFORMED ABOUT THE CONTAMINATION DETECTED" ¿PATIENT SAMPLES CHECKLIST: 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 3. WAS THERE ANY CHANGE OR DELAY OF TREATMENT DUE TO THE ISSUE? IF YES, GO TO QUESTION # 4. IF NO, GO TO QUESTION # 5. NO 4. PLEASE DESCRIBE ANY ADDITIONAL DETAILS. GO TO QUESTION # 5. 5. WAS THERE ANY PHYSICAL HARM/INJURY OR NEGATIVE IMPACT TO THE PATIENT DUE TO THE ISSUE? IF YES, GO TO QUESTION # 6. IF NO, NO FURTHER QUESTIONS REQUIRED. NO 6. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? GO TO QUESTION #7. 7. WHAT IS THE CURRENT MEDICAL STATUS? 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. PATIENT SAMPLES CONTAMINATED".

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA G.5. THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.