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

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1C (HBA1C) ASSAY ON A COBAS 6000 C501 (UL) V MODULE. INITIAL RESULT: 5.9 % (TESTED ON ANOTHER C501). THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS REPEATED AT THE SAME FACILITY AND AT A SISTER LABORATORY. 1ST REPEAT RESULT: 6.5 % (REPEATED ON THE C501). THE 2ND REPEAT RESULT OBTAINED FROM THE SISTER LABORATORY WAS DEEMED TO BE CORRECT.

Additional Manufacturer Narrative

THE C501 (UL) V MODULE SERIAL NUMBER WAS (B)(6). THE QC WAS RUNNING HIGH BUT STILL WITHIN RANGE. THE FIELD SERVICE ENGINEER FOUND THAT THE RINSE VOLUMES AT THE PROBE, RINSE BATHS, AND RINSE MECHANISMS WERE LOW. HE PERFORMED A HEALTH CHECK, CHECKED THE MECHANICAL ADJUSTMENTS OF THE PROBES, AND ADJUSTED RINSE VOLUMES AND PUMP PRESSURE. HE THEN PERFORMED CALIBRATION, QC, AND PRECISION STUDIES, AND THEY WERE WITHIN SPECIFICATIONS. THE ANALYZER WAS THEN PERFORMING WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE PROVIDED CALIBRATION RECOVERY WAS SUCCESSFUL WITH NO ALARMS, BUT IT SHOWED THAT THE CUSTOMER RECALIBRATED ONE APPLICATION WHILE NOT RECALIBRATING THE OTHER. THE ALARM TRACE SHOWED ABNORMAL PROBE SUCKING, ABNORMAL SAMPLE ASPIRATION, AND SAMPLE SHORT ALARMS. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE SERVICE ACTIONS PERFORMED BY THE FIELD SERVICE ENGINEER RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE CAUSE WAS TRACED TO MAINTENANCE.