MalfunctionJFP

ROCHE 9180 ELECTROLYTE ANALYZER

Received Dec 8, 2025 · Event occurred Nov 18, 2025

Report 1823260-2025-04997 · MDR key 23748327

Device

Generic name

Electrolyte Analyzer

Manufacturer

Roche Diagnostics

Catalog number

03157334001

Product problems

Incorrect Measurement
Chemical Problem
Device Ingredient or Reagent Problem
Chemical Problem
Device Ingredient or Reagent Problem

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM AND LITHIUM RESULTS FROM THE ROCHE 9180 ELECTROLYTE ANALYZER. FOR SAMPLE "AAA" THE SODIUM RESULTS WERE 140 MMOL/L, 140 MMOL/L, 140 MMOL/L, 140 MMOL/L, 140 MMOL/L, 126 MMOL/L, 140 MMOL/L, AND 140 MMOL/L. THE LITHIUM RESULTS WERE 0.47 MMOL/L, 0.47 MMOL/L, 0.48 MMOL/L, 0.47 MMOL/L, 0.47 MMOL/L, 0.83 MMOL/L, 0.47 MMOL/L, AND 0.46 MMOL/L. FOR SAMPLE "BBB" THE SODIUM RESULTS WERE 126 MMOL/L, 140 MMOL/L, 140 MMOL/L, AND 140 MMOL/L. THE LITHIUM RESULTS WERE 0.68 MMOL/L, 0.32 MMOL/L, 0.33 MMOL/L, AND 0.33 MMOL/L.