MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sodium electrode lot number was 31250347, with an install-before date of 12-sep-2025.The customer changed a system reagent pack and noticed an improvement in control performance and sample reproducibility.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant sodium electrode results for one patient sample tested on a roche 9180 electrolyte analyzer.The sample initially resulted in a sodium value of 142 mmol/l and it repeated as 170 mmol/l.The customer did not believe any of the values to be correct.No questionable results were reported outside of the laboratory as the results did not match the patient's clinical condition.
Additional Manufacturer Narrative
The customer later clarified that the 142 mmol/l sodium value was considered to be the correct value.
Additional Manufacturer Narrative
The calibration values for calibration standard a for na and k were within range, and the voltage difference in the calibration standards for na and cl were within the allowed range.However, the k a-b value was out of range in the 11:32 calibration, and the cl stand a value was out of range in the 17:35 calibration.No correction factors were applied.The investigation findings suggest that the problem likely stems from the interplay between specific core components within the system (reference electrode, na electrode, system reagent pack), along with potential deficiencies in the main instrument's operation.A specific root cause could not be determined.
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 analyzer.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: 22628877
• Report Number: 1823260-2025-02300
• Device Sequence Number: 8927691
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup,Followup
• Report Date (Section B): 12/18/2025

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: 07/07/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 09/11/2025; 12/11/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/18/2025; 09/24/2025; 12/18/2025
• 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