ALINITY I CEA REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED DISCREPANT ALINITY I CEA RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 (B)(6) 2023 RESULT WITH OLD LOT 49146FN00 = 2.0, (B)(6) 2023 RESULT WITH NEW LOT 50043FN00 = 3.1. ADDITIONALLY, THE CUSTOMER ALSO NOTED A SHIFT UP IN QUALITY CONTROLS. NO 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, AND DEVICE HISTORY RECORD REVIEW. 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. THE TICKET SEARCH BY LOT INDICATES THAT THE COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CEA REAGENT LOT 49146FN00 WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL 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 DISCREPANT ALINITY I CEA RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 (B)(6) 2023 RESULT WITH OLD LOT 49146FN00 = 2.0, (B)(6) 2023 RESULT WITH NEW LOT 50043FN00 = 3.1 ADDITIONALLY, THE CUSTOMER ALSO NOTED A SHIFT UP IN QUALITY CONTROLS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.