ROCHE 9180 ELECTROLYTE ANALYZER
Received May 9, 2025 · Event occurred Apr 14, 2025
Report 1823260-2025-01436 · MDR key 21993805
Device
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ELECTRODE LOT NUMBER WAS 31243847. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. PATIENT 1 INITIAL RESULT WAS 117 MMOL/L, AND THE REPEAT RESULT WAS 138 MMOL/L. PATIENT 2 INITIAL RESULT WAS 118 MMOL/L, AND THE REPEAT RESULT WAS 142 MMOL/L. PATIENT 3 INITIAL RESULT WAS 119 MMOL/L, AND THE REPEAT RESULT WAS 141 MMOL/L.
Additional Manufacturer Narrative
THE CUSTOMER REPLACED THE REFERENCE ELECTRODE HOUSING. THE INVESTIGATION DETERMINED THAT THE CUSTOMER'S ACTIONS RESOLVED THE ISSUE.