ELECSYS FT3 III

Additional Manufacturer Narrative

QC WAS ACCEPTABLE, HOWEVER, IT WAS NOT PROVIDED WHICH REAGENT PACK WAS USED. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE. PRECISION TESTING FROM 14-JAN-2024 WAS ACCEPTABLE. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH EITHER FOAM ON THE REAGENT SURFACE OR A SAMPLE CLOT IN THE MEASURING CELL. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 5 PATIENT SAMPLES TESTED FOR ELECSYS FT3 III (FT3 III) ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 40.3 PMOL/L. THE REPEAT RESULT WAS 4.81 PMOL/L. PATIENT 2 INITIAL RESULT WAS 10.8 PMOL/L. THE REPEAT RESULT WAS 4.10 PMOL/L. PATIENT 3 INITIAL RESULT WAS 9.88 PMOL/L. THE REPEAT RESULT WAS 4.99 PMOL/L. PATIENT 4 INITIAL RESULT WAS 7.27 PMOL/L. THE REPEAT RESULT WAS 5.85 PMOL/L. PATIENT 5 INITIAL RESULT WAS 7.70 PMOL/L. THE REPEAT RESULT WAS 5.41 PMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE CUSTOMER CHECKED HOW THE REAGENT PACK WAS BEING STORED AND NOTED THAT THE FT3 REAGENT PACK WAS LYING DOWN AND NOT UPRIGHT. THE 5 PATIENT SAMPLES WERE REPEATED LATER THE SAME DAY AND THE FT3 III RESULTS WERE REPRODUCIBLE. THE CUSTOMER SUSPECTS BUBBLES IN THE REAGENT AT THE TIME OF THE EVENT EARLIER IN THE DAY. THE INVESTIGATION IS ONGOING.