KIT BD MAX CTGCTV2 US

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D.1 MEDICAL DEVICE TYPE: MKZ AND OUY.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT BD MAX CTGCTV2 US THERE WAS A FALSE POSITIVE. EVENT 1 OF 2. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S DISCREPANT RESULTS. CUSTOMER PROBLEM: REPORTED FALSE POSITIVE ON 2 DIFFERENT PATIENTS ON CT AND SECOND RUN WITH DIFFERENT COLLECTED SAMPLES WERE NEGATIVE ON (B)(6). ONE PATIENT RAN ON SIDE A AND ANOTHER PATIENT ON SIDE B. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT BD MAX CTGCTV2 US THERE WAS A FALSE POSITIVE. EVENT 2 OF 2. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S DISCREPANT RESULTS. CUSTOMER PROBLEM: REPORTED FALSE POSITIVE ON 2 DIFFERENT PATIENTS ON CT AND SECOND RUN WITH DIFFERENT COLLECTED SAMPLES WERE NEGATIVE ON 08/30. ONE PATIENT RAN ON SIDE A AND ANOTHER PATIENT ON SIDE B. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE CORRECTED: D4. MEDICAL DEVICE LOT#: 3135908. D4. MEDICAL DEVICE EXPIRATION DATE: 10/19/2024. H4. DEVICE MANUFACTURE DATE: 05/15/2023.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT (REF. 443904) LOTS 3135908 AND 3137830 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT INDICATED THAT LOTS 3135908 AND 3137830 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT CT POSITIVE RESULTS ON TWO PATIENT SAMPLES, WHICH UPON REPEAT, WERE NEGATIVES FOR BOTH SAMPLES. THE COMPLAINT WAS OPENED ON KIT LOT 3137830, BUT ANALYSIS OF THE CUSTOMER DATA REVEALED THAT KIT LOT 3135908 WAS ALSO USED AND WAS INCLUDED IN THE INVESTIGATION. CUSTOMER PROVIDED DATABASE AND RUN FILES (984, 986, 995 AND 999) FROM INSTRUMENT CT2473 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION OF THE FIRST CT POSITIVE PATIENT SAMPLE (RUN 984, POSITION A1) REVEALED A LATE AND LOW BUT TRUE AMPLIFICATION WITHOUT ANOMALY INDICATIVE OF TRUE LOW POSITIVE RESULT. AFTER THE INITIAL RUN, A NEW SAMPLE BUFFER TUBE WAS PREPARED AND TESTED IN RUN 999 POSITION A3. THE CT VALUE OF THE AMPLIFICATION CURVE OF THE INTERNAL CONTROL IN THE REPEAT TEST WAS LATER THAN THE INITIAL TEST, WHICH COULD SUGGEST INHIBITION OF THE AMPLIFICATION REACTION AND COULD HAVE CONTRIBUTED TO THE NEGATIVE RESULT. NO AMPLIFICATION WAS VISIBLE FOR THE CT TARGET ON THE REPEAT. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, A SPECIMEN AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), ENVIRONMENTAL OR CROSS CONTAMINATION ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULT IN THE INITIAL TEST (RUN 984, POSITION A1) AND INHIBITION FROM THE USE OF INTERFERING SUBSTANCES IN THE SPECIMEN IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S NEGATIVE RESULT IN THE RE-TEST (RUN 999 POSITION A3). CURVES ANALYSIS OF THE SECOND CT POSITIVE PATIENT SAMPLE (RUN 986, POSITION B8) REVEALED A STEP DISLOCATION IN THE RAW PCR SIGNAL, RESULTING IN A POSITIVE RESULT FOR THE CT TARGET. IT IS UNLIKELY THAT THE STEP DISLOCATION IS DUE TO TRUE AMPLIFICATION, AND THIS IS FURTHER SUPPORTED BY THE FACT THAT THE RETEST SHOWS NO AMPLIFICATION. BD WAS UNABLE TO IDENTIFY A CAUSE FOR THE UNUSUAL PCR SIGNAL, BUT THE ISSUE SEEMED ISOLATED TO THIS EVENT. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOTS 3135908 AND 3137830. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE USING KIT BD MAX CTGCTV2 US THERE WAS A FALSE POSITIVE. EVENT 2 OF 2 THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S DISCREPANT RESULTS. CUSTOMER PROBLEM: REPORTED FALSE POSITIVE ON 2 DIFFERENT PATIENTS ON CT AND SECOND RUN WITH DIFFERENT COLLECTED SAMPLES WERE NEGATIVE ON 08/30. ONE PATIENT RAN ON SIDE A AND ANOTHER PATIENT ON SIDE B. HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT BD MAX CTGCTV2 US THERE WAS A FALSE POSITIVE. EVENT 2 OF 2 THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S DISCREPANT RESULTS. CUSTOMER PROBLEM: REPORTED FALSE POSITIVE ON 2 DIFFERENT PATIENTS ON CT AND SECOND RUN WITH DIFFERENT COLLECTED SAMPLES WERE NEGATIVE ON 08/30. ONE PATIENT RAN ON SIDE A AND ANOTHER PATIENT ON SIDE B. HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO.