ROCHE 9180 ELECTROLYTE ANALYZER
Received Aug 11, 2025 · Event occurred Jul 21, 2025
Report 1823260-2025-02439 · MDR key 22777170
Device
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE CUSTOMER STATED THAT QC WAS PASSING AT THE TIME OF THE EVENT, BUT WHEN IT IS RAN AS A PATIENT, THE VALUE IS LOWER. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF 3 QUESTIONABLE SODIUM ELECTRODE RESULTS FROM THE ROCHE 9180 ELECTROLYTE ANALYZER. PATIENT 1'S INITIAL RESULT WAS 118 MMOL/L, AND THE REPEAT RESULT FROM A COBAS PURE WAS 137 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 121 MMOL/L, AND THE REPEAT RESULT FROM A COBAS PURE WAS 138 MMOL/L. PATIENT 3'S INITIAL RESULT WAS 118 MMOL/L, AND THE REPEAT RESULT FROM A COBAS PURE WAS 137 MMOL/L.
Additional Manufacturer Narrative
THE CUSTOMER CHANGED ALL THE ELECTRODES AND TUBINGS, RESOLVING THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE, AS ADDITIONAL INFORMATION NECESSARY FOR THE INVESTIGATION WAS NOT AVAILABLE. IT WAS CONFIRMED THAT THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE, AND THE INSTRUMENT IS OPERATIONAL.