ALINITY M STI AMP KIT

Additional Manufacturer Narrative

INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW. ALL RELEVANT CUSTOMER DATA WAS REVIEWED. THE ASSAY MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE QUALITY CONTROL (QC) RUNS. THE INITIAL TEST OF THE SAMPLE RESULTED IN EC 9274 (CELLULAR CONTROL FAILED), RETEST OF THE SAME SAMPLE RESULTED AS CT TARGET NOT DETECTED BUT PRODUCED A SIGMOIDAL AMPLIFICATION CURVE AS THE MAX RATIO (MR) VALUE OF THE SAMPLE (MR = 0.042) DOES NOT MEET THE MR THRESHOLD OF THE CT ANALYTE (MR = 0.075). QUALITY DATA REVIEW. CAPA REVIEW. A PART AND KEYWORD SPECIFIC SEARCH WAS PERFORMED TO IDENTIFY RELATED EXISTING INTERNAL QUALITY RECORDS WHICH COULD RESULT IN THE REPORTED COMPLAINT AND PART NUMBER. THE PART AND KEYWORD SPECIFIC CAPA REVIEW DID NOT IDENTIFY ANY INTERNAL RECORDS OR NONCONFORMANCES RELATED TO THE CURRENT COMPLAINT FOR PART 9N17. COMPLAINT HISTORY REVIEW. A COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE CASE BEING INVESTIGATED. ADDITIONALLY, COMPLAINT TRENDING WAS REVIEWED. A TREND VIOLATION WAS NOT IDENTIFIED, AND THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PART 09N17 (TRENDING PART NUMBER). BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M STI APPLICATION SPECIFICATION (APPSPEC) FILE LIST 09N17-05B WAS NOT IDENTIFIED.

Description of Event or Problem

CUSTOMER CALLED TO REPORT CONCERN OF A FALSE NEGATIVE RESULT ON THE CHLAMYDIA (CT) TARGET WHEN RUNNING THE ALINITY M STI ASSAY. TECHNICAL APPLICATION SPECIALIST (TAS) PERFORMED LOG ANALYSIS. THE SAMPLE IN QUESTION IS SAMPLE ID (SID) (B)(6), TESTED ON 01DEC. THE RESULT WAS VALID, WITH INTERNAL CONTROL (IC) 31.48 AND CELLULAR CONTROL (CC) 33.53, AND WITH THE CT AND NG TARGETS AS "NOT DETECTED", WITH CYCLE NUMBER (CN) -1.00. HOWEVER, THE CUSTOMER OBSERVED THAT THE CT TARGET HAS A SIGMOIDAL AMPLIFICATION CURVE PRESENT. THE SAMPLE DID NOT GENERATE A POSITIVE RESULT DUE TO THE FACT THAT IT DID NOT MEET THE MINIMUM MAXRATIO (MR) VALUE FOR THE ASSAY. THE SAME SAMPLE HAD BEEN PREVIOUSLY TESTED ON 28NOV WITH A 9274 EXCEPTION (CELLULAR CONTROL FAILED). THE SAMPLE IS A RECTAL SWAB COLLECTED IN ALINITY M MULTICOLLECT AS PER PROCEDURE. COLLECTION OCCURRED ON 28NOV, THE TEST ON THAT DAY HAVING THE CC FAILURE, THEN RETESTED ON 01DEC AS DETAILED ABOVE. CUSTOMER LATER REPORTED THAT THIS SAMPLE WAS TESTED ON AN ALTERNATIVE METHOD, FOUND TO BE POSITIVE FOR CT, AND THUS ULTIMATELY REPORTED AS POSITIVE CT TEST TO THE PHYSICIAN/PATIENT. NO FURTHER PATIENT IMPACT HAS BEEN DECLARED.

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.