ELECSYS PROBNP II

Additional Manufacturer Narrative

THE SAMPLE WAS RECEIVED FOR INVESTIGATION ON 27-MAR-2025. THE SAMPLE WAS TESTED WITH 2 ELECSYS PROBNP II LOT KITS WITH ADDITIONAL DETECTION ANTIBODIES FOR THE MUTATIONS ON A COBAS E801 IMMUNOASSAY ANALYZER. THE INVESTIGATION RESULTS DETECTED THE MUTATION IN THE SAMPLE, LEADING TO FALSE-NEGATIVE TEST RESULTS FOR ELECSYS PROBNP II. THE CUSTOMER¿S RESULT WAS CONFIRMED. THIS TYPE OF POINT MUTATION IS EXTREMELY RARE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS DUE TO THE SAMPLE CONTAINING AN INTERFERING FACTOR.

Additional Manufacturer Narrative

THE PROBNP II REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS E801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION ON 14-FEB-2025. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE NOT MATCHING THE PATIENT'S CLINICAL DIAGNOSIS WHEN TESTED WITH ELECSYS PROBNP G2 (PROBNP II) ASSAY ON A COBAS E801 ANALYTICAL UNIT. THE CUSTOMER INITIALLY TESTED THE SAMPLE ON A VITROS SYSTEM AND THE RESULT WAS BELOW DETECTABILITY. THE CUSTOMER TESTED THE SAMPLE ON AN E801 AND THE RESULT WAS ALSO BELOW DETECTABILITY. THE CUSTOMER THEN DILUTED THE SAMPLE AND TESTED IT AGAIN AND THE RESULT WAS THE SAME AS THE PREVIOUS ONE. THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY FOR RE-TESTING AND THE BNP RESULT WAS ABOUT 300 PG/ML. ON 05-MAR-2025, THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A 2ND E801 ANALYZER RESULTING IN A PROBNP II VALUE OF 5.00 PG/ML AND ACCOMPANIED BY A DATA FLAG. THE CUSTOMER SUSPECTED A GENETIC MUTATION.