MalfunctionJGS

ISE SODIUM ELECTRODE

Received May 13, 2025 · Event occurred Apr 16, 2025

Report 1823260-2025-01479 · MDR key 22013130

Device

Generic name

Electrode, Ion Specific, Sodium

Manufacturer

Roche Diagnostics

Catalog number

09237216001

Lot number

ASKU

Product problems

Non Reproducible Results
Non Reproducible Results

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

SECTION D4 PRIMARY UDI NUMBER WAS ADDED.

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CALIBRATION WAS ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE REPLACED THE SYRINGE SEALS, PINCH TUBING, SIPPER AND VACUUM NOZZLES, AND CLEANED THE DILUTION NOZZLES. HE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. ALTHOUGH NO CAUSE FOR THE ISSUE WAS FOUND, THE INSTRUMENT PERFORMANCE WAS VERIFIED, AND THE ISSUE APPEARS TO BE RESOLVED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ISE SODIUM ELECTRODE RESULTS FOR 12 PATIENT SAMPLES AND QUESTIONABLE CHLORIDE ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 ISE 1800 MODULE. THIS MEDWATCH WILL APPLY TO THE ISE SODIUM ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CHLORIDE ELECTRODE. PATIENT 1: THE INITIAL NA RESULT IS 147 MMOL/L, AND THE REPEATED RESULT WAS 140 MMOL/L. PATIENT 2: THE INITIAL NA RESULT IS 144 MMOL/L, AND THE REPEATED RESULT WAS 134 MMOL/L. PATIENT 3: THE INITIAL NA RESULT IS 152 MMOL/L, AND THE REPEATED RESULT WAS 145 MMOL/L. PATIENT 4: THE INITIAL NA RESULT IS 145 MMOL/L, AND THE REPEATED RESULT WAS 137 MMOL/L. PATIENT 5: THE INITIAL NA RESULT IS 153 MMOL/L, AND THE REPEATED RESULT WAS 146 MMOL/L. PATIENT 6: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 143 MMOL/L. PATIENT 7: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 142 MMOL/L. PATIENT 8: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 142 MMOL/L. PATIENT 9: THE INITIAL NA RESULT IS 151 MMOL/L, AND THE REPEATED RESULT WAS 144 MMOL/L. PATIENT 10: THE INITIAL NA RESULT IS 142 MMOL/L, AND THE REPEATED RESULT WAS 134 MMOL/L. PATIENT 11: THE INITIAL CL RESULT IS 112 MMOL/L, AND THE REPEATED RESULT WAS 95 MMOL/L. PATIENT 12: THE INITIAL NA RESULT IS 150 MMOL/L, AND THE REPEATED RESULT WAS 143 MMOL/L. PATIENT 13: THE INITIAL NA RESULT IS 149 MMOL/L, AND THE REPEATED RESULT WAS 141 MMOL/L. THE SAMPLES WERE REPEATED DUE TO ALARMS IN THE CUSTOMER'S MIDDLEWARE.