ELECSYS PROBNP II

Additional Manufacturer Narrative

CALIBRATION SIGNALS WERE WITHIN EXPECTATIONS. NO QC WAS PERFORMED ON THE DAY OF THE EVENT. PER PRODUCT LABELING, "CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER COBAS E PACK, AND FOLLOWING EACH CALIBRATION". THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E801 ANALYZER IS (B)(6) . THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR APPROXIMATELY 80 PATIENT SAMPLES TESTED WITH ELECSYS PROBNP II ON A COBAS E 801 MODULE. CONTROLS TESTED ON (B)(6) 2024 WERE ACCEPTABLE AND PATIENT SAMPLES WERE MEASURED ON THE EVENING OF (B)(6) 2024 TO THE MORNING OF (B)(6) 2024. CONTROLS RECOVERED LOW ON THE MORNING OF (B)(6) 2024. THE CONTROLS WERE REPEATED, BUT REMAINED LOW. THE REAGENT PACK WAS THEN REPLACED AND CONTROLS WERE THEN ACCEPTABLE. THE CUSTOMER REPEATED THE PATIENT SAMPLES ON A SECOND ANALYZER. EXAMPLES WERE PROVIDED FOR 3 PATIENT SAMPLES WITH DISCREPANT PROBNP RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF 1160 PG/ML AND IT REPEATED AS 1520 PG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF 334 PG/ML AND IT REPEATED AS 450 PG/ML. THE THIRD SAMPLE INITIALLY RESULTED IN A PROBNP VALUE OF 263 PG/ML AND IT REPEATED AS 342 PG/ML.