ALINITY M STI AMP KIT

Additional Manufacturer Narrative

CORRECTION TO D4 CATALOG NUMBER AND UDI - THE CATALOG NUMBER WAS CORRECTED FROM 09N17-091 TO 09N17-090 AND THE UDI HAS ALSO BEEN CORRECTED TO REFLECT. INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: RETAIN EVALUATION: ALINITY M STI AMP KIT (LIST 09N17-090) LOT 381002 RETAIN SAMPLE WAS TESTED BY THE COMPLAINT SUPPORT TEAM. LOT 381002 MET ALL VALIDITY AND ACCEPTANCE CRITERIA WITH NO ERROR CODES. THE ASSAY LOT 383196 IS PERFORMING AS EXPECTED AND PASSED THE VALIDITY AND ACCEPTANCE CRITERIA. CUSTOMER DATA REVIEW: REVIEW OF THE CUSTOMER DATA WAS PERFORMED. THE RUN WHICH INVOLVED THE DISCREPANT RESULT WAS VALID AND MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE CONTROLS. THE DISCREPANT RESULT PRODUCED A VALID RESULT, AND THE AMPLIFICATION CURVE DID NOT APPEAR ABNORMAL. THE ASSAY IS PERFORMING AS EXPECTED WITH CORRECT INTERPRETATIONS. THE CN VALUES OF THE POSITIVE SAMPLES WERE BELOW THE CUTOFF FOR THE NG TARGET (CN = 40.00). A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS REVIEW. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW: REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M STI AMP KIT (LIST 09N17-090) LOT 381002 (INCLUDING THE COMPONENTS) DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE REPORTED COMPLAINT. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. THE QC TESTING MET ALL ACCEPTANCE AND VALIDITY SPECIFICATION CRITERIA. CAPA / NON-CONFORMANCE REVIEW: A CAPA REVIEW WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT FOR ALINITY M STI AMP KIT (LIST 09N17-090) LOT 381002 AND ITS COMPONENTS. THIS CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL ISSUES OR NONCONFORMANCES RELATED TO THE REPORTED COMPLAINT FOR ALINITY M STI AMP KIT (LIST 09N17-090) LOT 381002 OR ITS COMPONENTS. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY COMPLAINTS RELATED TO THE REPORTED ISSUE FOR THE AALINITY M STI AMP KIT (LIST 09N17-090) LOT 381002. TRENDING WAS REVIEWED; A TREND VIOLATION WAS NOT IDENTIFIED, AND THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PRODUCT PART 09N17. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS REVIEW. BASED ON THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY COULD NOT BE IDENTIFIED BY THIS REVIEW.

Additional Manufacturer Narrative

B3 AND B5 HAS BEEN UPDATED TO REFLECT ADDITIONAL INFORMATION FROM THE CUSTOMER. LOT NUMBER HAS BEEN IDENTIFIED AND THEREFORE D4 AND H4 HAVE BEEN UPDATED. G3 WAS INADVERENTLY OMITTED ON INITIAL SUBMISSION; THE DATE FOR G3 ON INITIAL SUBMISSION WAS 23 AUG 2023.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY OBSERVED DISCREPANT RESULTS WITH AN UNKNOWN NUMBER OF PATIENTS ON THE ALINITY M STI AMP KIT. IT IS UNKNOWN WHETHER THE RESULTS WERE FALSE POSITIVE, OR FALSE NEGATIVE. THE CUSTOMER REPORTED THAT THEY OBSERVED DISCREPANT RESULTS WHEN PROCESSING ON THE ALINITY M STI AMP KIT FOR TARGETS NEISSERIA GONORRHEA (NG) AND CHLAMYDIA TRACHOMATIS (CT). THE CUSTOMER DID REPORT THAT THEY HAD A RECENT CONTAMINATION EVENT, BUT IT IS UNKNOWN IF THAT WAS THE CAUSE OF THE ISSUE. IT WAS REPORTED THAT THE CUSTOMER TESTED SAMPLES, AND WHEN THEY HAVE A POSITIVE RESULT FOR NG OR CT THEY RE-TEST THE SAMPLE BY PROCEDURE. IT WAS REPORTED THAT SOME SAMPLES HAD NEGATIVE RESULTS ON THE RE-TEST. IT WAS REPORTED THAT THERE WAS NO IMPACT TO PATIENT MANAGEMENT. FURTHER PATIENT INFORMATION WAS NOT AVAILABLE, THEREFORE, THIS SUBMISSION IS CONSERVATIVELY BEING FILED AS A FALSE NEGATIVE EVENT. ON 20 SEP 2023, THE CUSTOMER CLARIFIED THAT THE ISSUE WAS ONLY RELATED TO THE NG TARGET, AND NOT THE CT TARGET AS INITIALLY INDICATED. THE FOLLOWING SAMPLES HAVE BEEN REPORTED BY THE CUSTOMER AS EXHIBITING THIS TEST RESULT PATTERN (POSITIVE ON INITIAL TEST, NEGATIVE ON RETEST). SID (B)(6). SID (B)(6) RUN DATE 20 AUG 23 RESULT NG POSITIVE, REPEATED 22 AUG 23 NEGATIVE. SID (B)(6) RUN DATE 24 AUG 23 RESULT NG POSITIVE, REPEATED 25 AUG 23 NEGATIVE SID (B)(6) RUN DATE 20 AUG 23 RESULT NG POSITIVE, REPEATED 21 AUG 23 NEGATIVE SID (B)(6). SID (B)(6), RUN DATE 12 SEP 23 RESULT NG POSITIVE, REPEATED 13 SEP 23 RESULT NEGATIVE. UPON EVALUATION OF RUN DATA ON THE CUSTOMER'S SYSTEM DURING TROUBLESHOOTING ON 21 SEP 23, THE FOLLOWING ADDITIONAL SIDS WERE IDENTIFIED AS EXHIBITING THIS TEST RESULT PATTERN (POSITIVE ON INITIAL TEST, NEGATIVE ON RETEST). SID (B)(6) RUN DATE 22 AUG 23 RESULT NG POSITIVE, REPEATED 23 AUG 23 RESULT NG POSITIVE. SID (B)(6) RUN DATE 22 AUG 23 RESULT NG POSITIVE, REPEATED 23 AUG 23 RESULT NG POSITIVE. SID (B)(6) RUN DATE 22 AUG 23 RESULT NG POSITIVE, REPEATED 23 AUG 23 RESULT NG POSITIVE. SID (B)(6) RUN DATE 20 AUG 23 RESULT ERROR CODE 1995 (FLUORESCENCE SIGNAL EVALUATION DID NOT MEET EXPECTED CRITERIA. NORMALIZED FLUORESCENCE IS TOO LOW), REPEATED 20 AUG 23 RESULT NG POSITIVE, REPEATED 22 AUG 23 RESULT NG POSITIVE THE CUSTOMER HAS NOT INDICATED THE ANTICIPATED RESULTS FOR ANY OF THE INDICATED SAMPLES AND THEREFORE NEITHER FALSE POSITIVE NG RESULTS NOR FALSE NEGATIVE NG RESULTS CAN BE RULED OUT. AS SUCH, THIS SUBMISSION REMAINS BEING CONSERVATIVELY BEING FILED AS A FALSE NEGATIVE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY OBSERVED DISCREPANT RESULTS WITH AN UNKNOWN NUMBER OF PATIENTS ON THE ALINITY M STI AMP KIT. IT IS UNKNOWN WHETHER THE RESULTS WERE FALSE POSITIVE, OR FALSE NEGATIVE. THE CUSTOMER REPORTED THAT THEY OBSERVED DISCREPANT RESULTS WHEN PROCESSING ON THE ALINITY M STI AMP KIT FOR TARGETS NEISSERIA GONORRHEA (NG) AND CHLAMYDIA TRACHOMATIS (CT). THE CUSTOMER DID REPORT THAT THEY HAD A RECENT CONTAMINATION EVENT, BUT IT IS UNKNOWN IF THAT WAS THE CAUSE OF THE ISSUE. IT WAS REPORTED THAT THE CUSTOMER TESTED SAMPLES, AND WHEN THEY HAVE A POSITIVE RESULT FOR NG OR CT THEY RE-TEST THE SAMPLE BY PROCEDURE. IT WAS REPORTED THAT SOME SAMPLES HAD NEGATIVE RESULTS ON THE RE-TEST. IT WAS REPORTED THAT THERE WAS NO IMPACT TO PATIENT MANAGEMENT. FURTHER PATIENT INFORMATION WAS NOT AVAILABLE, THEREFORE, THIS SUBMISSION IS CONSERVATIVELY BEING FILED AS A FALSE NEGATIVE EVENT.

Additional Manufacturer Narrative

ELEVATED COMPLAINT INVESTIGATION WILL BE PERFORMED.

Additional Manufacturer Narrative

UPDATED D2A DEVICE COMMON NAME FROM MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD, KIT, NUCLEIC ACID, TO NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S) CAUSING SEXUALLY TRANSMITTED INFECTIONS. UPDATED D2B PRODUCT CODE FROM LSL TO QEP.