BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENTRA C400

    MDR report key: 22943450 · Received September 2, 2025

    Report

    Report Number
    MW5175515
    Event Type
    Other
    Date Received
    September 2, 2025
    Report Date
    August 27, 2025
    Manufacturer
    HORIBA INSTRUMENTS/ HORIBA ABX SAS
    Product Code
    JJE
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PENTRA C400 IS FAILING CHLORIDE RESULTS ON PROFICIENCY TESTING FOR GOING ON 13+ YEARS. HORIBA HAS US REPLACE THE CHLORIDE ELECTRODE BEFORE TESTING WITH A NEW ONE THEY PROVIDE TO US. THEY KEEP TELLING US IT IS BEING WORKED ON AGAIN AND AGAIN AND AGAIN. CUSTOMERS ARE FAILING SOMETIMES THREE TIME IN A ROW WITH HIGH RESULTS OUTSIDE THE PEER GROUPS. HORIBA HAS EMAIL TRAILS AND SUPPOSEDLY ARE WORKING ON THIS BUT NOTHING HAS EVER BEEN REPORTED. HORIBA JAPAN TESTS THE ELECTRODES TO SEE WHICH ONES MAY OR MAY NOT FAIL BUT THEY FAIL STILL, THE FIELD REP COMES OUT TO VALIDATE MY SYSTEM AND GIVE ME A NEW ELECTRODE TO RUN PRIOR TO THE PROFICIENCY TESTING. WHEN I HAVE FAILED PRIOR HORIBA SEND THE FIELD REP OUT PRIOR TO THE NEXT TESTING TO PERFORM A PREVENTATIVE MAINTENANCE AND VALIDATE THE SYSTEM BY RUNNING THE OLD MATERIAL AND SEE IF IT PASSES. CHECK WITH FIELD REPS THIS IS THEIR FIX TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335543 PENTRA C400 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE HORIBA INSTRUMENTS/ HORIBA ABX SAS C400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown