BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER HB9210 HBA1C SYSTEM

    MDR report key: 21945095 · Received May 1, 2025

    Report

    Report Number
    1931251-2025-00001
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    February 20, 2025
    Report Date
    May 1, 2025
    Manufacturer
    TRINITY BIOTECH (PRIMUS CORPORATION)
    Product Code
    LCP
    UDI-DI
    05391516744751
    PMA / PMN Number
    K112015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195253 PREMIER HB9210 HBA1C SYSTEM PREMIER HB9210 HBA1C LCP TRINITY BIOTECH (PRIMUS CORPORATION) 09-00-0001 05391516744751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other