BD COR PX/MX

Additional Manufacturer Narrative

CORRECTION: B.1. ADVERSE TYPE: REPORTED ISSUE IS BOTH AND ADVERSE EVENT AND PRODUCT PROBLEM. B.2. EVENT ATTRIBUTED TO: REQUIRED INTERVENTION . B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE USING BD COR PX/MX THERE WAS A FALSE POSITIVE OF ONE PATIENT SAMPLE. RESULTS WERE REPORTED TO THE END USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PATIENT WAS POSITIVE FOR CT (CT:35.7) AND TV (CT:37,5). PATIENT HAS TAKEN 3 SAMPLES THAT ARE ALL COMPLETELY NEGATIVE." PATIENT GOT FULL TREATMENT (ONE WEEK WITH ANTIBIOTIC). H.1. TYPE OF REPORTABLE EVENTS: SERIOUS INJURY.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD COR PX/MX THERE WAS A FALSE POSITIVE OF ONE PATIENT SAMPLE. RESULTS WERE REPORTED TO THE END USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PATIENT WAS POSITIVE FOR CT (CT:35.7) AND TV (CT:37,5). PATIENT HAS TAKEN 3 SAMPLES THAT ARE ALL COMPLETELY NEGATIVE." PATIENT GOT FULL TREATMENT (ONE WEEK WITH ANTIBIOTIC).

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD COR MX INSTRUMENT (CATALOG NUMBER 443989 SERIAL NUMBER (B)(6) ) HAD A "FALSE POSITIVE" RESULT ON CTGCTV2 ASSAY. CUSTOMER REPORTED THAT A PATIENT WAS POSITIVE FOR CT WITH CT SCORE OF 35.7 AND TV WITH CT SCORE OF 37.5. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THE COMPLAINT IS THE ISSUE IS NOT RELATED TO MANUFACTURING. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT CRM0105 AND NO ADDITIONAL WORK ORDER WAS OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. RUN FILES AND LOGS WERE REVIEWED FOR INVESTIGATION. QUALITY HAS NOTED THAT THERE WERE MOMENTS OF NORMALIZER DRIFT ON ROX CHANNEL, BUT NONE WAS DRIFTING ENOUGH TO LEAD TO A FALSE POSITIVE. CT POSITIVE SAMPLE CURVES WERE REVIEWED. RAW CURVES ON FAM CHANNELS WERE SIGMODAL AND SMOOTH ON THREE DIFFERENT RUNS. NORMALIZER CURVE SHOWS RELATIVE FLATNESS, SHOWING THAT THE NORMALIZER WAS FUNCTIONING AS INTENDED ON THOSE THREE RUNS. QUALITY HAS DETERMINED THAT BASED ON THE CURVES THAT THERE ARE NO ISSUE WITH THE INSTRUMENT. REAGENT LOT CAN BE ELIMINATED AS THIS IS ONLY AFFECT ONE LANE AND NOT MULTIPLE LANES. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. COMPLAINT IS UNCONFIRMED BY QUALITY ENGINEERING. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW, MODIFIED, OR ADDITIONAL RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR TRENDS ASSOCIATED WITH THIS FAILURE MODE.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD COR PX/MX THERE WAS A FALSE POSITIVE OF ONE PATIENT SAMPLE. RESULTS WERE REPORTED TO THE END USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PATIENT WAS POSITIVE FOR CT (CT:35.7) AND TV (CT:37,5). PATIENT HAS TAKEN 3 SAMPLES THAT ARE ALL COMPLETELY NEGATIVE.". PATIENT GOT FULL TREATMENT (ONE WEEK WITH ANTIBIOTIC).

Additional Manufacturer Narrative

D.2B. MEDICAL DEVICE TYPE: MKZ, OUY, QEP. 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 PX/MX THERE WAS A FALSE POSITIVE OF ONE PATIENT SAMPLE. RESULTS WERE REPORTED TO THE END USER. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PATIENT WAS POSITIVE FOR CT (CT:35.7) AND TV (CT:37,5). PATIENT HAS TAKEN 3 SAMPLES THAT ARE ALL COMPLETELY NEGATIVE."