BD CTGCTV2 FOR BD MAX¿ SYSTEM (US

Description of Event or Problem

IT WAS REPORTED THAT BD CTGCTV2 FOR BD MAX¿ SYSTEM (US FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TV POS WITH LOT 20117628 ON WED 10/26 WITH URINE SAMPLE THAT WAS NEG ON 10/25 WITH KIT 442970 LOT 2137538. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. WHICH ASSAYS OR TESTS ARE EXHIBITING ISSUES? 443904. ARE THE VALUES OF THE ASSAYS AVAILABLE? PENDING ANALYZER NAME & MODEL #CT0620 HOW MANY UNITS (TUBES) AFFECTED? ONE WHAT IS THE FREQUENCY OR OCCURRENCE RATE (1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY TESTS PER DAY ETC.) ONE. WHAT WAS METHOD OF DRAW? URINE. IS TUBE FILLED TO STATED VOLUME? YES 2ML. HOW MANY TIMES WAS THE TUBE INVERTED? MIXED BUT UNKNOWN. HOW LONG AFTER COLLECTION WERE TUBES PROCESSED? WITHIN 24HRS".

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: . REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX CTGCTV2 INDICATED THAT LOT 2011762 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE PATIENT WAS RETESTED WITH THREE OTHER KIT LOTS AND GAVE A NEGATIVE RESULT EACH TIME, BUT NO DATA FROM THESE RESULTS WAS PROVIDED. TWO PDF RUNS (OF RUNS 8534 AND 8558) WERE RECEIVED FOR INVESTIGATION. RUN 8534 CONTAINS QC VALIDATION SAMPLES GIVING EXPECTED POSITIVE AND NEGATIVE RESULTS. RUN 8558 CONTAINS ONLY THE PATIENT SAMPLE CONCERNED BY THE COMPLAINT (LANE A12). PCR CURVES FROM THE PDF FILE SHOW WHAT APPEARS TO BE AN ATYPICAL CURVE IN THE CY5 CHANNEL (TV TARGET). IT IS UNLIKELY THAT THIS ATYPICAL CURVE IS THE RESULT OF TRUE AMPLIFICATION AND A PUNCTUAL ISSUE FROM AN UNKNOWN ORIGIN IS SUSPECTED. HOWEVER, WITHOUT A .CSV FILE, FURTHER ANALYSIS IS LIMITED. MOREOVER, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. OVERALL, BASED ON THE DATA ANALYZED, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX CTGCTV2 LOT 2011762. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

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 BD CTGCTV2 FOR BD MAX¿ SYSTEM (US FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TV POS WITH LOT: 20117628 ON WED 10/26 WITH URINE SAMPLE THAT WAS NEG ON 10/25 WITH KIT: 442970 LOT: 2137538. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. WHICH ASSAYS OR TESTS ARE EXHIBITING ISSUES? 443904. ARE THE VALUES OF THE ASSAYS AVAILABLE? PENDING. ANALYZER NAME & MODEL#: CT0620. HOW MANY UNITS (TUBES) AFFECTED? ONE. WHAT IS THE FREQUENCY OR OCCURRENCE RATE (1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY TESTS PER DAY ETC.) ONE. WHAT WAS METHOD OF DRAW? URINE. IS TUBE FILLED TO STATED VOLUME? YES 2ML. HOW MANY TIMES WAS THE TUBE INVERTED? MIXED BUT UNKNOWN. HOW LONG AFTER COLLECTION WERE TUBES PROCESSED? WITHIN 24HRS".