TINA-QUANT IGM GEN.2

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TINA-QUANT IGM GEN.2 ASSAY ON A COBAS 8000 C702 MODULE. ON (B)(6) 2026: INITIAL RESULT: 2894.9 MG/DL (ACCOMPANIED BY AN INVALIDATING DATA FLAG). 1ST REPEAT RESULT: 2816.1 MG/DL (TESTED WITH DILUTION). ON (B)(6) 2026: THE PHYSICIAN REQUESTED THAT A PROTEIN ELECTROPHORESIS BE PERFORMED, AND THE ELECTROPHORESIS IMAGE DID NOT CORRESPOND TO THE IGM VALUE, WHICH IS AROUND 2000 MG/DL. THE ORIGINAL SAMPLE WAS THEN REPEATED, AND THE 2ND REPEAT RESULT WAS APPROXIMATELY 300 MG/DL. NO EXACT RESULT WAS PROVIDED. ON (B)(6) 2026: 3RD REPEAT RESULT: 278 MG/DL. THE 2ND REPEAT RESULT OF APPROXIMATELY 300 MG/DL WAS DEEMED TO BE CORRECT.

Additional Manufacturer Narrative

THE C702 MODULE SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE WITHIN THE ACCEPTABLE RANGES. THE INVESTIGATION IS ONGOING.