ELECSYS CYFRA 21-1

Additional Manufacturer Narrative

THE CEA REAGENT LOT NUMBER WAS 749425 WITH AN EXPIRATION DATE OF 31-JAN-2025. THE HE4 REAGENT LOT NUMBER WAS 738510 WITH AN EXPIRATION DATE OF 31-MAR-2025. THE COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(6) . THE ALARM TRACE SHOWED MULTIPLE ABNORMAL SAMPLE ASPIRATION ALARMS AND ABNORMAL SAMPLE PROBE MOVEMENT ALARMS ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS NOT MATCHING THE PATIENT'S CLINICAL PICTURE FOR 1 PATIENT SERUM SAMPLE TESTED WITH ELECSYS CEA ASSAY, ELECSYS CYFRA 21-1 ASSAY, AND ELECSYS HE4 ASSAY ON A COBAS 8000 COBAS E602 MODULE WHEN COMPARED TO A NON-ROCHE ANALYZER. THIS MEDWATCH WILL APPLY TO THE CYFRA 21-1 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CEA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE HE4 ASSAY. THE SAMPLE WAS INITIALLY TESTED ON THE E602 ANALYZER AND REPEATED ON A NON-ROCHE ANALYZER ON (B)(6) 2024. TWO TEST RESULTS WERE CONSISTENT. CEA: INITIAL RESULT: 13.62 NG/ML. REPEAT RESULT: 13.37 NG/ML. CYFRA 21-1: INITIAL RESULT: 54.37 NG/ML. REPEAT RESULT: 55.767 NG/ML. HE4: INITIAL RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 1967.4 PMOL/L. REPEAT RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 4151.754 PMOL/L. THE ABOVE PATIENT TEST RESULTS WERE CONSIDERED HIGHER THAN THE NORMAL REFERENCE RANGE. THE CUSTOMER SUSPECTED AN INTERFERENCE.

Additional Manufacturer Narrative

ON (B)(6) 2024, THE HE4 RESULT WAS 98.37 PMOL/L AFTER A MANUAL DILUTION OF 1:20 USING DILUENT UNIVERSAL. THE CUSTOMER USED AN INCORRECT DILUTION SOLUTION FOR THE HE4 ASSAY. THE CUSTOMER WAS ADVISED TO USE DILUENT MULTIASSAY AS THE PRODUCT LABELING STATES: "SAMPLES WITH HE4 CONCENTRATIONS ABOVE THE MEASURING RANGE CAN BE DILUTED WITH DILUENT MULTIASSAY." ON 19-JUL-2024 THE SAMPLE WAS REQUESTED BUT IT WAS NOT AVAILABLE FOR INVESTIGATION. CALIBRATION AND QC DATA WERE REQUESTED BUT WERE NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CEA, CYFRA 21-1, AND HE4 REAGENTS PERFORM WITHIN THE SPECIFIED RANGES. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.