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	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The roche 9180 sodium electrode lot number is 31245047.Qc levels 1 and 2 were within the specified ranges.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable roche 9180 sodium electrode results from two patient samples tested on the electrolyte analyzer w/o starterkit 9180.Patient sample 1 the initial result was 113 mmol/l with a data flag.The repeat result was 139 mmol/l.Patient sample 2 the high result was 141 mmol/l.The low result was 115 mmol/l with a data flag.The low results were inconsistent with the patients' clinical state.The questionable results were not reported outside the laboratory.
Additional Manufacturer Narrative
In the initial medwatch, the first line of b5 describe event or problem should have been: "the initial reporter received questionable roche 9180 sodium electrode results from two patient samples tested on the roche 9180 electrolyte analyzer w/o starterkit 9180." instead of: "the initial reporter received questionable roche 9180 sodium electrode results from two patient samples tested on the electrolyte analyzer w/o starterkit 9180." the customer used a diamond diagnostics (dd ref electrode) for the roche 9180 electrolyte analyzer.The field service engineer replaced the reference and sodium electrodes, the electrode housing, and the analyzer's fluid, waste, and calibrator pack.The investigation reviewed the qcs; qc levels 1 and 2 results were within the specified ranges.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: 22356701
• Report Number: 1823260-2025-01977
• Device Sequence Number: 8655656
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: NU
• 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): 11/11/2025

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: 06/06/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 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