ALINITY I CEA REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I CEA RESULT ON ONE 63 YEAR OLD MALE PATIENT DIAGNOSED WITH ASTHMA/COPD/PULMONARY FIBROSIS/HISTORY OF SMOKING. THE PATIENT HAS NOT BEEN DIAGNOSED WITH CANCER. THE FOLLOWING DATA WAS PROVIDED: ALINITY RESULT PROCESSED ON (B)(6) 2024 = 46.31 NG/ML HISTORICAL RESULTS: (B)(6) 2024 = 40.9 NG/ML (B)(6) 2024 = 31.4 NG/ML (B)(6) 2021 = 16.8 NG/ML THE CUSTOMER REPORTED THAT A CHEST/ABDOMINAL CT SCAN(WITHOUT CONTRAST) AND A UPPER/LOWER DIGESTIVE ENDOSCOPY WAS PERFORMED DUE TO THE FALSELY ELEVATED ALINITY I CEA RESULT OF 40.9 NG/ML, BUT NO MALIGNANT TUMOR WAS FOUND. THE CUSTOMER STATED THERE WAS NO HARM TO THE PATIENT. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

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 A FALSELY ELEVATED ALINITY I CEA RESULT ON ONE 63-YEAR-OLD MALE PATIENT DIAGNOSED WITH ASTHMA/COPD/PULMONARY FIBROSIS/HISTORY OF SMOKING. THE PATIENT HAS NOT BEEN DIAGNOSED WITH CANCER. THE FOLLOWING DATA WAS PROVIDED: ALINITY RESULT PROCESSED ON (B)(6) 2024 = 46.31 NG/ML. HISTORICAL RESULTS: (B)(6) 2024 = 40.9 NG/ML. (B)(6) 2024 = 31.4 NG/ML. (B)(6) 2021 = 16.8 NG/ML. THE CUSTOMER REPORTED THAT A CHEST/ABDOMINAL CT SCAN (WITHOUT CONTRAST) AND A UPPER/LOWER DIGESTIVE ENDOSCOPY WAS PERFORMED DUE TO THE FALSELY ELEVATED ALINITY I CEA RESULT, BUT NO MALIGNANT TUMOR WAS FOUND. THE CUSTOMER STATED THERE WAS NO HARM TO THE PATIENT. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A TICKET SEARCH BY LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY TRENDS REGARDING COMMONALITIES FOR THE LOT NUMBER 54280FN00 AND COMPLAINT ISSUE. ACCURACY TESTING WAS PERFORMED AND MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF DATA HISTORY RECORDS DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER 54280FN00 AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE. BASED ON THE INVESTIGATION, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE, THEREFORE, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CEA REAGENT KIT, LOT 54280FN00 WAS IDENTIFIED.