ELECSYS CYFRA 21-1

Additional Manufacturer Narrative

DATA WAS REQUESTED FOR FURTHER INVESTIGATION BUT WAS NOT PROVIDED. THE CUSTOMER HAD DILUTED THE SAMPLE CONTRARY TO THE RECOMMENDATIONS PROVIDED IN THE PRODUCT LABELING. THE PRODUCT LABELING STATES: DILUTION. SAMPLES WITH CYFRA 21-1 CONCENTRATIONS ABOVE THE MEASURING RANGE CAN BE DILUTED WITH DILUENT UNIVERSAL. THE RECOMMENDED DILUTION IS 1:2 (EITHER AUTOMATICALLY BY THE ANALYZERS OR MANUALLY). THE CONCENTRATION OF THE DILUTED SAMPLE MUST BE > 250 NG/ML. AFTER MANUAL DILUTION, MULTIPLY THE RESULT BY THE DILUTION FACTOR. AFTER DILUTION BY THE ANALYZERS, THE SOFTWARE AUTOMATICALLY TAKES THE DILUTION INTO ACCOUNT WHEN CALCULATING THE SAMPLE CONCENTRATION." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE REAGENT PERFORMS WITHIN SPECIFICATIONS. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE COBAS E801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CYFRA 21-1 ASSAY ON A COBAS E801 ANALYTICAL UNIT. THE SAMPLE WAS INITIALLY TESTED ON AN E801 AND REPEATED 3 TIMES AT THE CUSTOMER'S SITE. THE SAMPLE WAS THEN TESTED ON ANOTHER E801 AT THE INVESTIGATION SITE. THE SAMPLE WAS ALSO TESTED ON AN ABBOTT ARCHITECT ANALYZER. INITIAL RESULT: >500 NG/ML. 1ST REPEAT RESULT: 425 NG/ML (TESTED WITH AN AUTOMATIC DILUTION WITH A DILUTION FACTOR OF 1:2). 2ND REPEAT RESULT: 372 NG/ML (TESTED WITH A MANUAL DILUTION WITH A DILUTION FACTOR OF 1:3). 3RD REPEAT RESULT: 338 NG/ML (TESTED WITH A MANUAL DILUTION WITH A DILUTION FACTOR OF 1:4). ON (B)(6) 2025: 4TH REPEAT RESULT: 484 NG/ML (TESTED ON ANOTHER E801 AT THE INVESTIGATION SITE). ON (B)(6) 2025: 5TH REPEAT RESULT: 270 NG/ML (TESTED ON ABBOTT ARCHITECT).