TRIGLYCERIDES

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE CALIBRATION AND QC WERE ACCEPTABLE. THE MAINTENANCE WAS PERFORMED PER THE SPECIFICATIONS. THE ALARM TRACE SHOWED MULTIPLE "ABNORMAL ASPIRATION" ALARMS, HINTING AT PRE-ANALYTICAL/SAMPLE-HANDLING ISSUES. THE PROVIDED REACTION KINETICS SHOWED AN IRREGULAR CURVE FOR THE INITIAL RUNS, INDICATING CONTAMINATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH TRIGLYCERIDES ASSAY ON A COBAS C 503 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 302 MG/DL. 1ST REPEAT RESULT: 416 MG/DL. 2ND REPEAT RESULT: 312 MG/DL. SAMPLE 2 WAS TESTED ON (B)(6) 2026: INITIAL RESULT: 250 MG/DL. REPEAT RESULT: 169 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.