ALINITY I CEA REAGENT KIT
Received Aug 16, 2023 · Event occurred Jul 10, 2023
Report 3008344661-2023-00155 · MDR key 17560295
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P62-30
Lot number
42723FN00
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 ALINITY I CEA RESULT FOR A CANCER PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID 406218372 INITIAL RESULT, ON (B)(6) 2023, WAS <2 UG/L. THE PATIENT WAS REDRAWN AND TESTED ON (B)(6) 2023, AND THE RESULT WAS 381 UG/L. THE PATIENT WAS REDRAWN AND TESTED ON (B)(6) 2023, AND THE RESULT WAS 321 UG/L. THE PATIENT¿S PREVIOUS RESULT, ON (B)(6) 2023, WAS 193 UG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR A FALSELY DECREASED ALINITY I CEA RESULT 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 TESTING OF THE COMPLAINT LOT. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE PRODUCT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. DEVICE HISTORY RECORD REVIEW ON LOT NUMBER 42723FN00 DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT. ACCURACY TESTING WAS PERFORMED USING PANELS, WHICH MIMICS PATIENT SAMPLES, AND AN IN-HOUSE RETAINED KIT OF LOT 42723FN00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I CEA, LOT NUMBER 42723FN00, WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I CEA RESULT FOR A CANCER PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON 10JUL, WAS <2 UG/L. THE PATIENT WAS REDRAWN AND TESTED ON 24JUL2023, AND THE RESULT WAS 381 UG/L. THE PATIENT WAS REDRAWN AND TESTED ON 31JUL2023, AND THE RESULT WAS 321 UG/L. THE PATIENT¿S PREVIOUS RESULT, ON 02JUL2023, WAS 193 UG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.