inforMED
OtherJJE

PENTRA C400

Received Sep 2, 2025

Report MW5175515 · MDR key 22943450

Device

Generic name

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

Model number

C400

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings
  • High Test Results

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.