MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sodium electrode lot number and expiration date were not provided.Qc was acceptable.The customer stated that the calibration was acceptable.The investigation determined that 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 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.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested for sodium on a roche 9180 electrolyte analyzer.Initial result: 125 mmol/l.The customer observed crystallization around the reference electrode and noticed that the initial result did not correlate with the patient's condition, and repeated the sample.Repeat result: 140 mmol/l (tested on a cobas pure instrument).The repeat result was deemed to be correct.No questionable results were reported outside the laboratory.

• 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: 23464157
• Report Number: 1823260-2025-04480
• Device Sequence Number: 15724567
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 11/04/2025

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): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 11/04/2025
• 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