BD COR GX INSTRUMENT

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD COR GX INSTRUMENT HAS DOUBT ON RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS THE CUSTOMER ALWAYS LOOKS THROUGH THE C-FILES AFTER RUNS AND HAS DOUBT ON RESULT. IN THE C-FILES CT VALUE FOR CY5, HPV P3 = 27,58 / FINAL RESULT IS NEGATIVE. FOR CUSTOMER A CT VALUE OF 27,58 SHOULD NOT PROVIDE A NEGATIVE RESULT AS CONCLUSION THE SAMPLE HAS BEEN RETEST ON THE 2ND BD COR CT VALUE = 27,51 AND CONCLUSION IS NEGATIVE (THE SAMPLE IS POSITIVE FOR HPV45 AND HPV P2, ON BOTH SYSTEM).

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD COR GX INSTRUMENT HAS DOUBT ON RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS THE CUSTOMER ALWAYS LOOKS THROUGH THE C-FILES AFTER RUNS AND HAS DOUBT ON RESULT. IN THE C-FILES CT VALUE FOR CY5, HPV P3 = 27,58 / FINAL RESULT IS NEGATIVE. FOR CUSTOMER A CT VALUE OF 27,58 SHOULD NOT PROVIDE A NEGATIVE RESULT AS CONCLUSION. THE SAMPLE HAS BEEN RETEST ON THE 2ND BD COR CT VALUE = 27,51 AND CONCLUSION IS NEGATIVE. (THE SAMPLE IS POSITIVE FOR HPV45 AND HPV P2, ON BOTH SYSTEM).

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD COR GX INSTRUMENT (CATALOG # 443990 / SN: (B)(6)) HAD A 'FALSE NEGATIVE". CUSTOMER EXPERIENCED A FALSE NEGATIVE RESULT FROM A CONSUMABLE COMPLAINT AND HAD DOUBT ABOUT RESULTS ON INSTRUMENT. APPLICATION SPECIALIST CAME ONSITE AND PRESENTED THEIR FINDINGS TO THE CUSTOMER. NO INSTRUMENT ISSUES WERE NOTED DURING THE VISIT. REVIEW OF DEVICE HISTORY RECORD FOR (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR A FAILURE AT INSTALL. DEVICE INSTALLED ON (B)(6) 2019, AND SINCE THEN, OTHER SERVICE ACTIVITIES HAVE OCCURRED, SUCH AS PM OR REPAIR, WHICH CHANGED CONFIGURATION OF INSTRUMENT SINCE RELEASE FROM MANUFACTURING. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6) AND NO ADDITIONAL WORK ORDER WAS OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. SAMPLES WERE NOT EXPECTED TO BE RETURNED FOR INVESTIGATION, THEREFORE RETURNED SAMPLE ANALYSIS IS NOT PERFORMED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. COMPLAINT WAS UNCONFIRMED BY APPLICATION SPECIALIST. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW, MODIFIED, OR ADDITIONAL RISKS ASSOCIATED WITH THIS FAILURE MODE.