ELECSYS TG II

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TG II ON A COBAS E 801 MODULE. THE SAMPLE INITIALLY RESULTED IN A TG VALUE OF 1.09 NG/ML AND REPEATED AS 0.0400 NG/ML. THE SAMPLE WAS REPEATED FOUR TIMES ON (B)(6) 2024, RESULTING IN TG VALUES OF 0.0447 NG/ML, 0.509 NG/ML, 0.493 NG/ML, AND 0.499 NG/ML. THE SAMPLE WAS REPEATED THREE TIMES ON (B)(6) 2024, EACH TIME RESULTING IN TG VALUES OF 0.0400 NG/ML.

Additional Manufacturer Narrative

UPON REVIEW OF ALARM DATA, VARIOUS SAMPLE QUALITY RELATED ALARMS WERE OBSERVED, INCLUDING SAMPLE FOAM, SAMPLE CLOT, AND SAMPLE SHORT ALARMS. THESE ALARMS INDICATE A SAMPLE HANDLING ISSUE. A GENERAL REAGENT PROBLEM CAN BE EXCLUDED BASED ON THE PROVIDED DATA. AT THE TIME OF THE EVENT, THE MEASURING CELLS WERE OVERDUE FOR REPLACEMENT. THE MEASURING CELLS WERE REPLACED ON (B)(6) 2024. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT ANALYZER MAINTENANCE AND INSUFFICIENT SAMPLE HANDLING.