ELECSYS PROBNP II

Additional Manufacturer Narrative

THE INVESTIGATION REVIEWED THE LAST CALIBRATION PERFORMED ON (B)(6) 2024 AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE (B)(6) 2024 AND THE RESULTS WERE WITHIN SPECIFICATIONS; THE (B)(6) 2024 QC RECOVERY RESULTS WERE WITHIN +/- 3 STANDARD DEVIATIONS (SD). THE INVESTIGATION REVIEWED THE ALARM TRACE AND NUMEROUS PRECLEAN SHORT ALARMS WERE OBSERVED DURING THE RUN. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE AND DETERMINED THE CONTAMINATED EXTRA WASH STATION (EWS) HAD CAUSED THE EVENT. HE THEN FLUSHED THE EWS LINE AND REAGENT LINES. HE CHECKED THE SYRINGES AND PINCH VALVES. HE PERFORMED AIR PURGES ON THE EWS AND REAGENT PROBES AND MULTIPLE MEASURING CELL PREPARATIONS. THE CUSTOMER PERFORMED QCS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROBNP II (PROBNP II) I RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE TWO PATIENT SAMPLES WITH DISCREPANT RESULTS: SAMPLE 1 THE INITIAL RESULT WAS 11367 PG/ML. THE REPEAT RESULT WAS 8047 PG/ML. SAMPLE 2 THE INITIAL RESULT WAS 16036 PG/ML. THE REPEAT RESULT WAS 11144 PG/ML. THE REPORTER STATED THAT ALL QC LEVELS WERE OUT OF THE >3 STANDARD DEVIATION RANGE, PROMPTING THE RERUN OF THE PATIENT SAMPLES. THE REPEAT RESULTS WERE DEEMED CORRECT.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.