ARCHITECT CEA REAGENT KIT

Additional Manufacturer Narrative

THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

Additional Manufacturer Narrative

HEALTH EFFECT IMPACT CODE: F26. COMPONENT CODE: G01003. D8. WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. THE COMPLAINT INVESTIGATION FOR THE OBSERVED POTENTIAL FALSE DEPRESSED CEA RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELLING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. PERFORMANCE OF REAGENT LOT 19654FN00 WAS EVALUATED USING WORLD WIDE DATA FROM ABBOTTLINK. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 19654FN00 IS WITHIN THE ESTABLISHED CONTROL LIMITS, THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. PREVENTIVE ACTIONS (CAPA) REVIEW ON LOT 19654FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS RELATED TO THE CURRENT COMPLAINT ISSUE. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CEA ASSAY, LOT NUMBER 19654FN00, WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT CEA RESULT OF <0.5 NG/ML FOR A PATIENT SAMPLE THAT RETESTED AT 1130 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.