ELECSYS CYFRA 21-1

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 8000 - COBAS E 602 MODULE IS 1342-19. THE INVESTIGATION REVIEWED THE CALIBRATION DATA. THE CALIBRATION PERFORMED ON (B)(6) 2023 SHOWED THAT CALIBRATION SIGNALS FOR CALIBRATOR LEVEL 1 WERE WITHIN THE EXPECTED RANGE, BUT WERE BELOW FOR CALIBRATOR LEVEL 2. THE CALIBRATION PERFORMED ON (B)(6) 2023 USING THE AFFECTED REAGENT PACK SHOWED THAT CALIBRATION SIGNALS FOR CALIBRATOR LEVEL 1 WERE ABOVE THE EXPECTED RANGE, BUT FAR BELOW THE EXPECTED RANGE FOR CALIBRATOR LEVEL 2; THE AFFECTED REAGENT PACK SEEMS TO BE NOT WELL CALIBRATED. THE INVESTIGATION REVIEWED THE CUSTOMER'S QC RESULTS. THE RESULTS WERE WITHIN RANGE BUT CLOSE TO -2.5 STANDARD DEVIATIONS (SD) ON (B)(6) 2023 FOR LEVEL 2. THE INVESTIGATION REVIEWED THE ALARM TRACE; TWO (2) "ABNORMAL SAMPLE ASPIRATION" ALARMS WERE FOUND ON (B)(6) 2023. THE INVESTIGATION REVIEWED PICTURES OF THE AFFECTED REAGENT PACK; THERE WAS NO OBVIOUS DAMAGE TO THE REAGENT PACK. THE INVESTIGATION DETERMINED THE CUSTOMER'S ACTION (REPLACING THE REAGENT PACK) RESOLVED THE ISSUE. A GENERAL REAGENT PROBLEM CAN BE EXCLUDED BECAUSE ANOTHER REAGENT PACK OF THE SAME LOT PERFORMED ACCORDING TO SPECIFICATIONS AT THE CUSTOMER¿S AND AT OTHER CUSTOMERS¿ SITES. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CYFRA 21-1 (CYFRA 21-1) RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THE RESULTS FROM THE AFFECTED REAGENT PACK WERE HIGHER AND WERE NOT CLINICALLY SUITABLE COMPARED TO THE RESULTS FROM THE NEW REAGENT PACK WITH THE SAME LOT NUMBER. THE AFFECTED REAGENT PACK WAS RECALIBRATED; QC PASSED BUT THE PATIENT RESULTS WERE STILL ABNORMAL. THE (B)(6) 2023 INITIAL RESULTS WERE OBTAINED FROM THE AFFECTED REAGENT PACK. THE (B)(6) 2023 FIRST REPEAT RESULTS WERE OBTAINED FROM A NEW REAGENT PACK. THE (B)(6) 2023 SECOND REPEAT RESULTS WERE OBTAINED FROM THE AFFECTED REAGENT PACK AFTER RECALIBRATION AND QC. SAMPLE ID (B)(6). ON (B)(6) 2023, THE INITIAL RESULT WAS 85.97 NG/ML. ON (B)(6) 2023, THE FIRST REPEAT RESULT WAS 2.77 NG/ML. ON (B)(6) 2023, THE SECOND REPEAT RESULT WAS 57.28 NG/ML. SAMPLE ID (B)(6). ON (B)(6) 2023, THE INITIAL RESULT WAS 122.6 NG/ML. ON (B)(6) 2023, THE FIRST REPEAT RESULT WAS 2.63 NG/ML. ON (B)(6) 2023, THE SECOND REPEAT RESULT WAS 184.5 NG/ML. SAMPLE ID (B)(6). ON (B)(6) 2023, THE INITIAL RESULT WAS 365.9 NG/ML. ON (B)(6) 2023, THE FIRST REPEAT RESULT WAS 3.59 NG/ML. ON (B)(6) 2023, THE SECOND REPEAT RESULT WAS 416.8 NG/ML.