ARCHITECT I1000SR ANALYZER

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT PATIENT SAMPLE ((B)(6)) WAS TESTED FOR (B)(6) ON INSTRUMENT (B)(4) AND WAS REPORTED AS (B)(6) ON (B)(6) (LOT 22131LP19) AND (B)(6) (LOT 22131LP19). THE SAME SAMPLE WAS TESTED ON INSTRUMENT (B)(4) AND WAS REPORTED AS (B)(6) ON (B)(6) (LOT 18131LP14) AND (B)(6) (LOT 18131LP14). THE SAMPLE WAS RETESTED AT THE LAB AND REPORTED AS (B)(6). THE SAMPLE WAS ALSO SENT TO A REFERENCE LAB AND WAS CONFIRMED (B)(6). NO OTHER DISCREPANT RESULTS WERE REPORTED FROM INSTRUMENT (B)(4) IN THE TIMEFRAME THAT THE NONREACTIVE RESULTS WERE GENERATED FOR PATIENT SAMPLE ((B)(6)). ABBOTT POSITIVE CONTROL WAS RAN ON BOTH ANALYZERS ON DEC (B)(6). THE POSITIVE CONTROL CV RESULT OF (B)(6) IS WITHIN THE (B)(6) PACKAGE INSERT CLAIM. THE OUTCOME OF THIS TESTING CONFIRMS EQUIVALENCE BETWEEN THE TWO INSTRUMENTS IS WITHIN SPECIFICATION. A REVIEW OF INSTRUMENT LOGS ((B)(4)) WAS PERFORMED AND NO SYSTEMATIC ISSUES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE WERE IDENTIFIED DURING THE REVIEW OF THE INSTRUMENT (B)(4) LOGS. A SEARCH FOR SIMILAR COMPLAINTS WAS PERFORMED ON (B)(6) 2013. NO SIMILAR COMPLAINTS OF (B)(6) RESULTS ATTRIBUTED TO THE (B)(4) WERE IDENTIFIED. NO COMPLAINTS OF (B)(6) RESULTS WERE IDENTIFIED AGAINST THE REAGENT LOT CITED IN THE CURRENT COMPLAINT UNDER INVESTIGATION. BASED ON THE EVALUATION RESULTS, NO DEFICIENCY OR MALFUNCTION WERE IDENTIFIED TO BE RELATED TO THIS ISSUE. THE CUSTOMER WAS ADVISED THAT THE ARCHITECT SYSTEM HAS BEEN VALIDATED FOR ITS INTENDED USE. HOWEVER, ERRORS CAN OCCUR DUE TO POTENTIAL OPERATOR ERRORS AND ARCHITECT SYSTEM TECHNOLOGY LIMITATIONS. THE TROUBLESHOOTING SECTION LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS. THE ARCHITECT (B)(4) REAGENT PACKAGE INSERT LIMITATIONS OF THE PROCEDURE SECTION STATES THAT IF THE (B)(6) RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. THE CUSTOMER WAS ALSO ADVISED THAT (B)(6) RESULT AT ANY TIME DOES NOT PRECLUDE THE POSSIBILITY OF EXPOSURE TO INFECTION WITH (B)(6). ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS. THE SPECIFIC PERFORMANCE CHARACTERISTICS SENSITIVITY SECTION OF THE PACKAGE INSERT STATES THE ARCHITECT (B)(4) ASSAY DEMONSTRATED A SPECIFICITY OF > 99.0% IN A STUDY TESTING SAMPLES THAT WERE CONFIRMED AS TRUE (B)(6).

Description of Event or Problem

THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED (B)(6) RESULTS FOR THE ARCHITECT (B)(4) ASSAY USING REAGENT LOT 18131LP14. THE PATIENT HAD (B)(6) RESULTS WHEN TESTED WITH ANOTHER ARCHITECT ANALYZER ON THE SAME DATE USING A DIFFERENT REAGENT LOT 22131LP19. THE SAMPLE WAS (B)(6) WHEN TESTED AT THE CUSTOMER'S LAB AND WAS ALSO (B)(6) WHEN TESTED AT A REFERENCE LAB. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

(B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.