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); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable sodium electrode results with multiple patient samples on a roche 9180 electrolyte analyzer.The following example for one patient was provided: the initial result was 113 mmol/l.The repeat results were 113 mmol/l and 139 mmol/l, respectively.The normal result was deemed correct (139 mmol/l).
Additional Manufacturer Narrative
The electrode lot number is 31244547.The expiration date was requested, but it was not provided.Calibration and qc were within the expected ranges.The investigation is ongoing.
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 (b)(4) 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 (b)(4) 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: 23585450
• Report Number: 1823260-2025-04687
• Device Sequence Number: 15828938
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 12/05/2025

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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/05/2025
• 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 Age: 6 YR
• Patient Sex: Male