ALINITY I CEA REAGENT KIT

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, PATIENT IDENTIFIER = SID= 301(B)(6). PATIENT INFORMATION: NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I CEA RESULT ON SEVERAL PATIENTS. THE CUSTOMER STATES FALSELY DECREASED RESULTS WITH LOT NUMBER 28024FN01, SERIAL NUMBER (B)(6) AFTER CHANGED SAME LOT NUMBER DIFFERENT SERIAL NUMBER (B)(6) AND RESULT ARE NORMAL FOR PATIENTS AND CONTROLS. THE RESULTS PROVIDED WERE: FIRST RESULTS FROM SERIAL NUMBER (B)(6) /SECOND RESULTS FROM SERIAL NUMBER (B)(6) SID (B)(6) =(B)(6) NG/ML /SECOND RESULT=(B)(6) NG/ML. LABORATORY REFERENCE RANGE FOR CEA: 0.00 TO 5.00 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA OF ARCHITECT CEA REAGENT LOT 28024FN01. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF COMPLAINTS DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. THE REASON FOR THE DIFFERENCE IN RESULTS OBSERVED IS POTENTIALLY DUE TO REAGENT OR SPECIMEN INTEGRITY ISSUES OR INSTRUMENTATION ISSUES AT TIME OF TESTING. PRODUCT LABELLING PROVIDES INSTRUCTIONS FOR REAGENT STORAGE AND HANDLING TO ENSURE OPTIMUM RESULTS. THIS INCLUDES ADVICE THAT REAGENTS ARE SUSCEPTIBLE TO THE FORMATION OF FOAM AND BUBBLES. BUBBLES MAY INTERFERE WITH THE DETECTION OF THE REAGENT LEVEL IN THE CARTRIDGE AND CAUSE INSUFFICIENT REAGENT ASPIRATION THAT MAY ADVERSELY AFFECT RESULTS. IN ADDITION DO NOT REUSE ORIGINAL REAGENT CAPS OR REPLACEMENT CAPS DUE TO THE RISK OF CONTAMINATION AND POTENTIAL TO COMPROMISE REAGENT PERFORMANCE. PER THE LIMITATIONS OF THE PROCEDURE SECTION OF THE PRODUCT PACKAGE INSERT, A SERUM OR PLASMA CEA LEVEL, REGARDLESS OF VALUE, SHOULD NOT BE INTERPRETED AS ABSOLUTE EVIDENCE FOR THE PRESENCE OR ABSENCE OF MALIGNANT DISEASE. THE CEA LEVEL SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL EVALUATION AND OTHER DIAGNOSTIC PROCEDURES. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CEA REAGENT LOT 28024FN01.