ELECSYS T4

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE CUSTOMER NOTED THE ISSUE STARTED WHEN THE STAND-BY REAGENT KIT WAS SWITCHED.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 7 PATIENT SAMPLES TESTED FOR ELECSYS T4 (T4) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FOR ALL 7 PATIENT SAMPLES WAS >24.9 UG/DL WITH A DATA FLAG. PATIENT 1 REPEAT RESULT WAS 5.97 UG/DL. PATIENT 2 REPEAT RESULT WAS 5.55 UG/DL. PATIENT 3 REPEAT RESULT WAS 3.91 UG/DL. PATIENT 4 REPEAT RESULT WAS 4.16 UG/DL. PATIENT 5 REPEAT RESULT WAS 8.74 UG/DL. PATIENT 6 REPEAT RESULT WAS 5.65 UG/DL. PATIENT 7 REPEAT RESULT WAS 5.10 UG/DL.

Additional Manufacturer Narrative

THE CUSTOMER DID NOT PERFORM QC ON THE REAGENT PACK BEFORE USE. PRODUCT LABELING STATES: "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 DETERMINED THE EVENT WAS DUE TO A REAGENT HANDLING ISSUE AT THE CUSTOMER SITE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

SECTIONS D4, CATALOG NUMBER, AND UDI WERE UPDATED.