HORIBA MEDICAL PENTRA C400
Received Jun 16, 2025 · Event occurred May 1, 2025
Report MW5171520 · MDR key 22213827
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Horiba Abx SasProduct problems
- Material Integrity Problem
- Therapeutic or Diagnostic Output Failure
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
HORIBA MEDICAL PENTRA C400 CHEMISTRY SYSTEM HAS CONSISTENTLY FAILED API TESTING FOR THE CHLORIDE ELECTRODE. MULTIPLE CUSTOMERS FAIL EACH TIME THE PROFICIENCY TESTING IS THROUGHOUT THE YEAR. WE AS CUSTOMERS ARE BEING TOLD BY THE MANUFACTURER (HORIBA) TO REPLACE THE CHLORIDE ELECTRODE PRIOR TO RUNNING THE API TESTS. WE HAVE BEEN TOLD AND TOLD THAT THEY ARE WORKING ON THE ISSUE AND STILL NO RESOLUTION. WE ARE BEING TOLD IT IS ONLY HAPPENING WITH PROFICIENCY TESTING. BUT IF WE KEEP FAILING WE WILL NOT BE ABLE TO REPORT THE CHLORIDE RESULT. HORIBA'S RESPONSE IS TO REPLACE THE ELECTRODE. SOMETIMES WE REPLACE THE ELECTRODE BEFORE THE TESTING AND WE STILL FAIL THE PROFICIENCY.