ACCESS CEA

Description of Event or Problem

THE CUSTOMER REPORTED ERRONEOUS REPRODUCIBLE ELEVATED CEA (ACCESS CEA (CARCINOEMBRYONIC ANTIGEN), PART NUMBER 33200 AND LOT NUMBER 295069) WERE GENERATED FOR ONE (1) PATIENT ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) ON (B)(6) 2002. ON (B)(6) 2022 THE CUSTOMER REPORTED A CHANGE TO PATIENT TREATMENT OR MANAGEMENT OCCURRED IN CONJUNCTION WITH THE INCIDENT. THE PATIENT UNDERWENT A FIBROSCOPY AND AN ENDOSCOPY. THERE WAS NO FURTHER REPORT OF CHANGE TO PATIENT TREATMENT OR PATIENT OUTCOME. THE ORIGINAL CEA PATIENT RESULT WAS OVER RANGE (OVR FLAGGED) >994.0 G/L ON (B)(6) 2022 (9:31). IT WAS MANUALLY DILUTED AND FOLLOWING RESULTS WERE OBTAINED: 5.5 G/L AND 5.7 G/L WHEN DILUTED 1/10 ON (B)(6) 2022. ON (B)(6) 2002 THE PATIENT SAMPLE WAS TESTED FOR CEA; RESULTS OF 939.8 G/L AND 968.9 G/L WERE OBTAINED. ON (B)(6) 2022, PATIENT SAMPLE WAS TESTED AS FOLLOWS: 1.4 G/L WHEN DILUTED 1/2 AND 2841.5 G/L WHEN DILUTED AT 1/10. THE CUSTOMER¿S DILUTION WERE NOT LINEAR. THE PATIENT SAMPLE WAS ALSO TESTED FOR CEA USING THE ROCHE COBAS METHOD; RESULTS WERE LOW AT 3.4 NG/ML (<4.7 NG/ML) ON (B)(6) 2022 AND 3.1 NG/ML ON (B)(6) 2022 (SECOND SAMPLE). NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. THE SAMPLE WAS COLLECTED ON A SERUM TUBE, IT WAS CLEAR, THE CLOT TIME WAS GREATER THAN 30 MINUTES, IT WAS CENTRIFUGED AT 2000 G FOR 10 MINUTES. THE CUSTOMER AGREED TO SEND THE PATIENT SAMPLE TO BECKMAN COULTER FOR INVESTIGATIVE TESTING.

Additional Manufacturer Narrative

THE FULL IDENTIFIER FOR THIS EVENT IS (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS WEIGHT, ETHNICITY OR RACE. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. THE SAMPLE WAS COLLECTED ON A SERUM TUBE, IT WAS CLEAR, THE CLOT TIME WAS GREATER THAN 30 MINUTES, IT WAS CENTRIFUGED AT 2000 G FOR 10 MINUTES. THE CUSTOMER AGREED TO SEND THE PATIENT SAMPLE TO BECKMAN COULTER FOR INVESTIGATIVE TESTING. THE PATIENT SAMPLE WAS RECEIVED AND INTERFERENCE TESTING WAS PERFORMED BY THE BECKMAN COULTER COMPLAINT HANDLING UNIT (CHU). INTERFERENCE TESTING DEMONSTRATED PRESENCE OF INTERFERENCE RELATED TO ALKALINE PHOSPHATASE AND WAS THE CAUSE OF THE ERRONEOUS ELEVATED CEA RESULTS. IN CONCLUSION, THE CAUSE OF THE ERRONEOUS ELEVATED CEA RESULTS WAS THE PRESENCE OF ALKALINE PHOSPHATASE INTERFERENT IN THE PATIENT SAMPLE.