ALINITY M STI AMP KIT

Additional Manufacturer Narrative

AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M STI ASSAY, LIST NUMBER 09N17-091, WHICH IS THE SAME/ SIMILAR TO THE ALINITY M STI ASSAY, LIST NUMBER 09N17-095, WHICH RECEIVED FDA APPROVAL.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHILE RUNNING THE ALINITY M STI AMP KIT. SAMPLE ID (SID) (B)(6) WAS PROCESSED ON (B)(6) WITH A POSITIVE RESULT FOR CT TARGET, CYCLE NUMBER (CN) VALUE 37.2. CURVE ANALYSIS SHOWED A NORMAL AMPLIFICATION CURVE FOR CT, CELLULAR CONTROL AND THE INTERNAL CONTROL. CN VALUE OF THE TARGET CLOSE TO CUT OFF, CN 39. SAME SAMPLE WAS REPEATED (SID (B)(6) AND WAS PROCESSED ON (B)(6) WITH A NEGATIVE RESULT FOR CT TARGET. CURVES ARE FLAT. NORMAL AMPLIFICATION FOR THE CELLULAR CONTROL AND THE INTERNAL CONTROL. A VALID QC WAS AVAILABLE. THE POSITIVE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

FOLLOWING FIELDS HAVE BEEN UPDATED: H5 SELECTED "NO". INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW, RETAIN/FILE SAMPLE REVIEW, AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW: REVIEW OF THE CUSTOMER DATA DEMONSTRATED THAT THE ASSAY MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THE AMPLIFICATION CURVE FOR THE INITIAL POSITIVE TEST SHOWED NORMAL AMPLIFICATION IN BOTH BASELINED AND RAW DATA. THE NEGATIVE RETESTS DID NOT GENERATE ANY AMPLIFICATION. THE INITIAL RESULT REPORTED A FRACTIONAL CYCLE NUMBER (FCN) OF 37.2 WHICH IS NEAR THE CT TARGET CUTOFF OF 39.0, INDICATING A WEAK POSITIVE SAMPLE. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW REVIEW OF THE MANUFACTURING PACKETS FOR THE ALINITY M STI AMP KIT (LIST 09N17-091) LOT 410346 (INCLUDING COMPONENTS) DID NOT IDENTIFY ANY ISSUES THAT COULD RESULT IN THE REPORTED COMPLAINT. NO ISSUES OR RECORDS RELATED TO THE REPORTED COMPLAINT WERE FOUND THAT INCLUDE ANY ISSUES WHICH COULD HAVE LED TO THE REPORTED COMPLAINT. THE QUALITY CONTROL (QC) AMP KIT MASTERLOT TESTING FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 410346 (INCLUDING COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE FOUND DURING QC TESTING. CAPA / NON-CONFORMANCE REVIEW A LOT SPECIFIC CAPA SEARCH WAS PERFORMED TO IDENTIFY EXISTING INTERNAL QUALITY RECORDS RELATED TO THE REPORTED COMPLAINT. THE LOT SPECIFIC CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL RECORDS OR NONCONFORMANCES RELATED TO THE REPORTED. RETAIN/FILE SAMPLE REVIEW: THE FILE SAMPLE EVALUATION FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT NUMBER 410346 MET ALL ACCEPTANCE CRITERIA AS THE VALIDITY OF THE RUNS MET ALL ASSAY REQUIREMENTS. THERE WERE NO ERROR CODES OR PERFORMANCE RELATED FLAGS EXHIBITED FOR THE RUN CONTROLS. ALL REPLICATES WERE INTERPRETED CORRECTLY. THEREFORE, THE FILE SAMPLE EVALUATION FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT NUMBER 410346 RECEIVED A DISPOSITION OF PASS. COMPLAINT HISTORY REVIEW THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RELATED TO THE REPORTED ISSUE FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT NUMBER 410346. COMPLAINT TRENDING WAS REVIEWED, AND THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PRODUCT 9N17 (BASE LIST PART NUMBER). NO NEW ADVERSE TREND WAS IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT NUMBER 410346 WAS NOT IDENTIFIED.