BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD

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 DURING USE WITH BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS WERE OBTAINED AND REPORTED TO A CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT LOOKS LIKE THE LYRICS AREN'T SCANNING THE BARCODES IN THE LOADER TO VERIFY THE WORKLIST - WE'VE REASON TO BELIEVE A WORKLIST WAS LOADED INCORRECTLY, BUT NO ALERT WAS GIVEN! WE'VE ENABLED THE OPTION IN THE PREFERENCES - IS THERE ANYTHING ELSE WE SHOULD BE DOING TO ENABLE THIS FEATURE, OR IS THERE A PROBLEM WITH THE SOFTWARE / HARDWARE? 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 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 IF NO, GO TO QUESTION *5: NO 4.PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO QUESTION *5: A BATCH OF HLA-B27 RESULTS WAS AFFECTED, AND WE KNOW AT LEAST ONE HAS BEEN REPORTED INCORRECTLY AS NEGATIVE INSTEAD OF POSITIVE (WE¿RE CURRENTLY WAITING ON MOLECULAR RESULTS TO CONFIRM THE CORRECT RESULT FOR THE OTHER AFFECTED SAMPLES). FORTUNATELY THE CLINICAL IMPACT OF THIS IS RELATIVELY LOW, AS DIAGNOSIS OF ASSOCIATED CONDITIONS SHOULD BE BASED ON THE CLINICAL PRESENTATION RATHER THAN HLA-B27 RESULTS ALONE, AND THE ASSAY ISN¿T CONSIDERED CLINICALLY URGENT (I.E. WAITING TO GET THE CORRECT RESULTS FROM MOLECULAR TESTING AND ISSUING AMENDED REPORTS ISN¿T LIKELY TO SIGNIFICANTLY IMPACT THE PATIENT¿S CLINICAL MANAGEMENT. 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

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF ERRONEOUS RESULTS DUE TO BARCODE LABEL ISSUES WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: REVIEW OF COMPLAINT HISTORY FOR ANY SIMILAR COMPLAINTS. THE POTENTIAL CAUSE OF THE ISSUE WAS DETERMINED TO BE A USER WORKFLOW ISSUE. THE FSE INVESTIGATED THE ISSUE AND CONFIRMED THAT THE INSTRUMENT ITSELF WAS FUNCTIONING AS EXPECTED AND PROVIDED RECOMMENDATIONS FOR MORE SUITABLE BARCODE LABELS AND BETTER WORKFLOW STEPS. NO ONE WAS HARMED OR INJURED, AND THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT. REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS NO PARTS WERE REPLACED.

Description of Event or Problem

T WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ERRONEOUS RESULTS WERE OBTAINED AND REPORTED TO A CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT LOOKS LIKE THE LYRICS AREN'T SCANNING THE BARCODES IN THE LOADER TO VERIFY THE WORKLIST - WE'VE REASON TO BELIEVE A WORKLIST WAS LOADED INCORRECTLY, BUT NO ALERT WAS GIVEN! WE'VE ENABLED THE OPTION IN THE PREFERENCES - IS THERE ANYTHING ELSE WE SHOULD BE DOING TO ENABLE THIS FEATURE, OR IS THERE A PROBLEM WITH THE SOFTWARE / HARDWARE? 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 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 IF NO, GO TO QUESTION *5: NO. 4.PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO QUESTION *5: A BATCH OF HLA-B27 RESULTS WAS AFFECTED, AND WE KNOW AT LEAST ONE HAS BEEN REPORTED INCORRECTLY AS NEGATIVE INSTEAD OF POSITIVE (WE¿RE CURRENTLY WAITING ON MOLECULAR RESULTS TO CONFIRM THE CORRECT RESULT FOR THE OTHER AFFECTED SAMPLES). FORTUNATELY, THE CLINICAL IMPACT OF THIS IS RELATIVELY LOW, AS DIAGNOSIS OF ASSOCIATED CONDITIONS SHOULD BE BASED ON THE CLINICAL PRESENTATION RATHER THAN HLA-B27 RESULTS ALONE, AND THE ASSAY ISN¿T CONSIDERED CLINICALLY URGENT (I.E. WAITING TO GET THE CORRECT RESULTS FROM MOLECULAR TESTING AND ISSUING AMENDED REPORTS ISN¿T LIKELY TO SIGNIFICANTLY IMPACT THE PATIENT¿S CLINICAL MANAGEMENT. 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.