ALINITY I CEA REAGENT KIT
Received Nov 15, 2023 · Event occurred Nov 1, 2023
Report 3008344661-2023-00191 · MDR key 18145515
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P62-20
Lot number
50043FN00
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY DEPRESSED ALINITY I CEA RESULT FOR A PATIENT SAMPLE. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH CANCER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6): TESTED WITH ANALYZER AI21440 = < 1.73 NG/ML. SAMPLE ID (B)(6): RETESTED TESTED WITH ANALYZER AI24617 = 9.86 NG/ML. SAMPLE ID (B)(6): RETESTED WITH ANALYZER AI21440 = 9.62 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
A1 - PATIENT IDENTIFIER: (B)(6) (COMPLETE SAMPLE ID) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
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, IN-HOUSE TESTING, AND FIELD DATA 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. 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 50043FN00 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 50043FN00 AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WITH THE ALINITY I CEA REAGENT LOT 50043FN00 WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY DEPRESSED ALINITY I CEA RESULT FOR A PATIENT SAMPLE. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH CANCER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6): TESTED WITH ANALYZER AI21440 = < 1.73 NG/ML. SAMPLE ID (B)(6): RETESTED TESTED WITH ANALYZER AI24617 = 9.86 NG/ML. SAMPLE ID (B)(6): RETESTED WITH ANALYZER AI21440 = 9.62 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.