TINA-QUANT HEMOGLOBIN A1CDX GEN.3

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. THE RESULTS ALLEGEDLY DO NOT MATCH THE PATIENT'S CLINICAL CONDITION. THE PHYSICIAN EXPECTED LOWER PATIENT RESULTS BASED ON RESULTS OBTAINED WITH A CONTINUOUS BLOOD MONITOR (CBM) DEVICE. THE PATIENT'S CONTINUOUS BLOOD MONITOR SHOWS A GLUCOSE MANAGEMENT INDICATOR RESULT BELOW 7 %. THE PATIENT'S AVERAGE CBM GLUCOSE IS 145 MG/DL. THE CBM IS REPLACED EVERY 15 DAYS AND IT CORRECTLY PLACED. ON (B)(6) 2026, A FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HBA1C VALUE OF 7.7%. ON (B)(6) 2026, A SECOND SAMPLE COLLECTED FROM THE PATIENT WAS TESTED TWICE, EACH TIME RESULTING IN AN HBA1C VALUE OF 8.2 %. ON (B)(6) 2026, A THIRD SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HBA1C VALUE OF 7.9 %.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE INSTRUMENT AND THE REAGENT ARE PERFORMING AS SPECIFIED BASED ON THE PROVIDED DATA. HBA1C VALUES AND CGM TESTING RESULTS CANNOT BE DIRECTLY COMPARED.