BD FACSLYRIC¿

Additional Manufacturer Narrative

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 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 AFTER USE OF THE BD FACSLYRIC¿ FOREIGN MATTER/CONTAMINATION IN THE INSTRUMENT THAT IMPACTED PATIENT RESULTS WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE 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 THE #3. IF NO, NO FURTHER QUESTION: NO. CONTAMINATION CHECKLIST: 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. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLE CHECKLIST: CUSTOMER STATED THERE IS CONTAMINATION ON THE SPECIMEN. IT WAS REPORTED BY THE CUSTOMER THAT THE SIT FLUSH/VACUUM ISSUE CUSTOMER PROBLEM: SIT FLUSH/VACUUM ISSUE CUSTOMER CALLED IN STATING THAT THE SPECIMEN HAS BEEN CONTAMINATED AS THE SIT FLUSHES DOES NOT WORK PROPERLY. CUSTOMER HAS NOTICED THAT EVEN AFTER HAVING THE SIT FLUSH THERE ARE RESIDUAL DRIPS OF SPECIMEN ON THE SIT WHICH DRIPS. CUSTOMER STATED THAT IT HAS BEEN HAPPENING FOR 5 MONTHS PLUS BUT THE SAMPLES WERE STILL GOOD HOWEVER THIS TIME THE SPECIMENS WERE CONTAMINATED. CUSTOMER HAS TRIED ALL THE TROUBLESHOOTING BUT ISSUE STILL PERSISTED. SIT FLUSH DOES NOT WORK -IT SHOULD DROP IT HAPPENS ON BOTH MODES: TUBE AND LOADER.

Description of Event or Problem

IT WAS REPORTED THAT AFTER USE OF THE BD FACSLYRIC¿ FOREIGN MATTER/CONTAMINATION IN THE INSTRUMENT THAT IMPACTED PATIENT RESULTS WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE 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 THE #3. IF NO, NO FURTHER QUESTION: NO CONTAMINATION CHECKLIST: 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. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLE CHECKLIST: CUSTOMER STATED THERE IS CONTAMINATION ON THE SPECIMEN IT WAS REPORTED BY THE CUSTOMER THAT THE SIT FLUSH/VACUUM ISSUE. CUSTOMER PROBLEM: SIT FLUSH/VACUUM ISSUE CUSTOMER CALLED IN STATING THAT THE SPECIMEN HAS BEEN CONTAMINATED AS THE SIT FLUSHES DOES NOT WORK PROPERLY. CUSTOMER HAS NOTICED THAT EVEN AFTER HAVING THE SIT FLUSH THERE ARE RESIDUAL DRIPS OF SPECIMEN ON THE SIT WHICH DRIPS. CUSTOMER STATED THAT IT HAS BEEN HAPPENING FOR 5 MONTHS PLUS BUT THE SAMPLES WERE STILL GOOD HOWEVER THIS TIME THE SPECIMENS WERE CONTAMINATED. CUSTOMER HAS TRIED ALL THE TROUBLESHOOTING BUT ISSUE STILL PERSISTED. SIT FLUSH DOES NOT WORK -IT SHOULD DROP IT HAPPENS ON BOTH MODES: TUBE AND LOADER.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF A POTENTIAL CARRYOVER WAS 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 FOR EVALUATION AS THE DEFECTIVE PART WAS DISCARDED. POTENTIAL CAUSE WAS DUE TO A WORN DEGASSER ASSEMBLY AND THE ISSUE WAS RESOLVED AFTER REPLACEMENT. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE ANY PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.