PREMIER HB9210 HBA1C SYSTEM

Additional Manufacturer Narrative

TRINITY BIOTECH ARE CONTINUING TO REQUEST DATA OR SUPPORTING EVIDENCE REGARDING THE POTENTIALLY DISCREPANT RESULTS.

Description of Event or Problem

ON (B)(6) 2025, THE CUSTOMER STATED THAT THEY OBSERVED ERROR CODES DURING ONE SHIFT WHILE OPERATING THE PREMIER HB9210 HBA1C SYSTEM, AND THE SAMPLES WERE LEFT FOR THE NEXT SHIFT TO RUN. THE NEXT SHIFT RAN THE QC, WHICH FAILED. THEY THEN PROCEED TO REPLACE THE COLUMNS ON TO THE SYSTEM, RECALIBRATED, AND THEN RAN QC. WITH PASSING QC, PATIENT SAMPLES WERE RAN AND IT WAS OBSERVED THAT 70% OF THE SAMPLES DID NOT MEET "MATCHING" CRITERIA BETWEEN PREMIER HB9210 ANALYZERS. THE CUSTOMER STATES THAT THEIR CRITERIA IS THE SAMPLES MUST MATCH WITHIN 8%, BUT THEY SAID THEY OBSERVED 15-30% VARIATION BETWEEN THE SAMPLES RAN ON THE DIFFERENT ANALYZERS. THE CUSTOMER STATES THAT THEY PERFORMED A LOOK BACK ON PREVIOUSLY RAN PATIENT RESULTS AND OBSERVED 800 SAMPLES THAT DID NOT MEET THEIR "MATCHING" CRITERIA AND THE TESTS WERE REPEATED. TRINITY BIOTECH ARE NOT ABLE TO CONFIRM IF THE PATIENT DATA WAS AUTOMATICALLY RELEASED FROM THEIR LABORATORY INFORMATION SYSTEM (LIS). THE CUSTOMER STATED THAT A NOTIFICATION WAS SENT FOR THE 800 POTENTIALLY DISCREPANT RESULTS. BASED ON THESE NOTIFICATIONS, THE CUSTOMER CLAIMS THAT THEY HAVE BEEN ADVISED THAT SOME PATIENTS HAD BEEN INCORRECTLY PRESCRIBED MEDICATION. CURRENTLY, NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER REGARDING THE POTENTIALLY DISCREPANT RESULTS. THERE HAS BEEN NO ALLEGATION OF SERIOUS HEALTH RISK, DEATH, OR ADVERSE HARM REGARDING THIS EVENT. A FIELD SERVICE ENGINEER ATTENDED THE CUSTOMER SITE AND PERFORMED AN INVESTIGATION ON THE ANALYZER WHICH IDENTIFIED THE REAGENT MANIFOLD (COMPONENT) AS THE CAUSE OF THE SYSTEM'S ERROR CODE. THIS COMPONENT WAS REPLACED DURING THE SERVICING AND THE ERROR CODE ISSUE WAS RESOLVED. CURRENTLY NO OTHER INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER.