MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the roche 9180 sodium electrode on a roche 9180 electrolyte analyzer.The customer noted that the issue occurs after they change a system reagent pack.The customer also mentioned that the electrodes were replaced recently.The system reagent pack was replaced, maintenance was performed, and the system was calibrated.The sample issues occurred after these actions.The first sample initially resulted in a sodium value of 144 mmol/l and it repeated as 126 mmol/l.The second sample initially resulted in a sodium value of 141 mmol/l and it repeated as 125 mmol/l.
Additional Manufacturer Narrative
The sodium electrode lot number was 31250347, with an expiration date of 12-sep-2025.The field service engineer inspected the analyzer.No signs of crystallization were observed.The system reagent pack was replaced and calibration failed after this.The system reagent pack was re-inserted and maintenance was performed on the instrument, but calibration still failed.This process was repeated three times, with the same result.All tubing was replaced, maintenance was repeated, and calibration was successful.Controls recovered within range.Precision studies were performed with patient material and were successful.A review of the error report showed several error events between 14-jul-2025 and 19-aug-2025.Errors include sample sensor errors, electrode errors, calibration errors, power failure errors, and electrode errors.Base on photographs of the sodium electrode and reference electrode, no defects were observed.A review of manufacturing and release documentation showed that all components passed the internal manufacturing and quality control checks, meeting all required specifications.A manufacturing defect can be ruled out.Quality controls were acceptable.The investigation determined the issue likely stems from the interplay of specific core components within the system (reference electrode, na electrode, the system reagent pack), along with potential deficiencies in the main instrument's operation.
Additional Manufacturer Narrative
The root cause of the issue was related to a reference electrode manufactured by diamond diagnostics (dd ref electrode) used with the 9180 electrolyte analyzer.The reference electrode used (dd ref electrode) is covered by a roche initiated recall.Customers using the dd ref electrode were instructed to immediately stop using sodium (na) results from their 9180 analyzers.The affected reference electrode was not distributed in the united states.Customers in the united states use roche reference electrode and reference electrode housing.No further action is needed for customers in the united states.

• Brand Name: ROCHE 9180 ELECTROLYTE ANALYZER
• Common Device Name: ELECTROLYTE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22937196
• Report Number: 1823260-2025-02695
• Device Sequence Number: 21305327
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K961458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03157334001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown