ARCHITECT CEA REAGENT

Description of Event or Problem

THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED A LOWER THAN EXPECTED RESULT OF 1.56 (UNIT OF MEASURE WAS NOT PROVIDED) FOR THE ARCHITECT CEA ASSAY. THE RESULT WAS SUSPECTED BY THE CUSTOMER AS IT DID NOT MATCH WITH THE PREVIOUS RESULT OF 42. THE SAMPLE WAS RETESTED AND RESULTS OF 43.37 AND 43.67 WERE GENERATED AND REPORTED OUT. 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K68 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06C02.

Additional Manufacturer Narrative

CORRECTION IS ADDED TO SECITON D4 (PRODUCT CATALOG NUMBER WAS CHANGED FROM 07K68-37 TO 07K68-32). PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. HISTORICAL REVIEW SHOWED NO ADVERSE TREND FOR THIS LIST NUMBER FOR THIS ISSUE. THERE IS NO ATYPICAL COMPLAINT ACTIVITY FOR THIS PRODUCT LOT. A REVIEW OF THE MANUFACTURING AND TESTING DATABASE WAS ALSO PERFORMED FOR ARCHITECT CEA REAGENT 7K68-32 LOT 24311LF00 AND NO ISSUES WERE IDENTIFIED. NO RETURN MATERIAL WAS AVAILABLE FOR THIS COMPLAINT, HOWEVER THE CUSTOMER RE-ASSESSED THE SAMPLE TWICE AND WERE SATISFIED WITH THE HIGHER RESULTS OBTAINED. THE DISCREPANT RESULT MAY POTENTIALLY BE DUE TO SAMPLE INTEGRITY / HANDLING ISSUES. THE CUSTOMER IS DIRECTED TO THE ARCHITECT CEA REAGENT PACKAGE INSERT (SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS SECTION) WHICH INSTRUCTS THE USER ON INSPECTING THE SAMPLE (CHECK FOR BUBBLES, FIBRIN, PARTICULATE MATTER, CROSS-CONTAMINATION..). THE PACKAGE INSERT ALSO INSTRUCTS THE USER TO ENSURE THAT COMPLETE CLOT FORMATION IN SERUM SPECIMENS HAS TAKEN PLACE PRIOR TO CENTRIFUGATION. SOME SPECIMENS, ESPECIALLY THOSE FROM PATIENTS RECEIVING ANTICOAGULANT OR THROMBOLYTIC THERAPY MAY EXHIBIT INCREASED CLOTTING TIME. IF THE SPECIMEN IS CENTRIFUGED BEFORE A COMPLETE CLOT FORMS, THE PRESENCE OF FIBRIN MAY CAUSE ERRONEOUS RESULTS. IN ADDITION, TSB (TECHNICAL SERVICE BULLETIN) PRESSURE MONITORING SLOPE SCORE OPTION INSTALLATION MAY BE OF HELP TO THE CUSTOMER. THE TSB PROVIDES MORE STRINGENT ASPIRATION CHECKS AND MAKES THE INSTRUMENT REJECT MARGINAL SAMPLES RATHER THAN PROCESS THEM AND RISK PRODUCING ERRONEOUS RESULTS. THIS TSB HAS BEEN PROVIDED TO CSS IN RELATION TO THIS COMPLAINT. BASED ON THE EVALUATION RESULTS, IT WAS DETERMINED THAT THE ARCHITECT CEA REAGENT 7K68-32 LOT 24311LF00 IS PERFORMING ACCEPTABLY AND NO DEFICIENCY OR MALFUNCTION WAS IDENTIFIED.