MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode serial numbers and their expiration dates were requested but not provided.The event occurred after the customer replaced the new sodium electrode and reference housing with a non-roche reference electrode.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable sodium electrode and potassium electrode results from patient samples tested on the roche 9180 electrolyte analyzer.The following are examples of discrepant results: the initial sodium result was 109 mmol/l with a data flag.The repeat result was 135 mmol/l with a data flag.A repeat result of 107 mmol/l with a data flag was also reported.It is not clear if the following results are from the same patient sample: the initial potassium result was 3.7 mmol/l.The repeat result was 4.2 mmol/l.
Additional Manufacturer Narrative
The customer confirmed that the reported results were from the same patient sample.The initial results were obtained without a calibration, while the repeat results were obtained after a calibration.The investigation noted that the event occurred after the customer installed a non-roche reference electrode.The investigation determined that the event was consistent with the interaction of the non-roche reference electrode, roche sodium electrode, calibrator, and the analyzer.Product labeling states, "after installing a new electrode, daily maintenance, calibration, and qc measurements on 3 levels have to be performed to verify the performance of the electrode.".
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 the sodium (na) results from their 9180 analyzer.The affected reference electrode was not distributed in the united states.Customers in the united states use the roche reference electrode and the 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: 22540474
• Report Number: 1823260-2025-02186
• Device Sequence Number: 20986242
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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
• Report Date (Section B): 11/11/2025

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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 10/22/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/27/2025; 11/11/2025
• 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