TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION

Additional Manufacturer Narrative

HBA1C REAGENT LOT 83940601 HAS AN EXPIRATION DATE OF 31-JUL-2026. HBA1C REAGENT LOT 88803001 HAS AN EXPIRATION DATE OF 31-MAR-2027. CALIBRATION DATA SHOWED NO ALARMS, BUT CONTROLS SHOWED IMPRECISION AND SIGNIFICANT INCREASE AFTER THE CALIBRATION PERFORMED ON 17-APR-2026. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ON A COBAS INTEGRA 400 PLUS. THE CUSTOMER STATES THAT MOST PATIENT RESULTS FOR HBA1C HAVE BEEN ABOVE THE REFERENCE RANGE IN ROUTINE TESTING. THESE ARE SAMPLES FROM YOUNG PATIENTS, WITHOUT COMORBIDITIES, AND WITH NO HISTORY OF ALTERED GLYCEMIA. THE CUSTOMER HAS TRIED DIFFERENT REAGENT CASSETTES AND HAVE TRIED RECALIBRATING, BUT THE ISSUE PERSISTS. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT HBA1C RESULTS. THE PATIENT SAMPLE WAS TESTED USING REAGENT LOT 83940601, RESULTING IN AN HBA1C VALUE OF 6.02 %. THE PATIENT SAMPLE WAS TESTED USING REAGENT LOT 88803001, RESULTING IN AN HBA1C VALUE OF 5.51 %.