TINA-QUANT ALBUMIN GEN.2

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 89 MG/DL ON (B)(6)2025, THEN THE SAMPLE WAS DILUTED 1:3 AND THE RESULT WAS <0.3 MG/DL. ON (B)(6)2025 THE SAMPLE WAS RE-CENTRIFUGED AND THE RESULT WITHOUT DILUTION WAS 0.00585 MD/DL ACCOMPANIED WITH A <TEST FLAG. FOLLOWING THE RESULT OF 0.00585 MG/DL THEY REPEATED THE SAMPLE AT A DECREASED VOLUME AND THE RESULT WAS 95.2 MG/DL. A DILUTION OF 1:20 WAS PERFORMED AND THE RESULT WAS 111 MG/DL. A MANUAL DILUTION WAS COMPLETED OF 1:2 WITH A DECREASED VOLUME AND THE RESULT WAS 54.2 MG/DL. ON (B)(6)2025 THEY COMPLETED A 1:50 DILUTION AND THE RESULT OBTAINED WAS 124 MG/DL. THE QUESTIONABLE RESULTS WERE REPEATED BECAUSE THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT. THE CUSTOMER SUSPECTED A POTENTIAL INTERFERENCE.

Additional Manufacturer Narrative

THERE IS NOT ENOUGH INFORMATION PROVIDED TO DETERMINE THE ROOT CAUSE OF THE EVENT.