MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number and expiration date were not provided.Calibration and qc were acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable ion-selective electrode (ise) results for 2 patients¿ samples tested on a roche 9180 electrolyte analyzer.Results for the sodium (na) test were affected.Sample 1: na: initial result: 109 mmol/l.Repeat result: 142 mmol/l.Sample 2: na: initial result: 107 mmol/l.Repeat result: 136 mmol/l.The customer questioned the initial results and repeated the samples.The repeat results were deemed to be correct.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
Correction: sample 1: initial result: 142 mmol/l.Repeat result: 109 mmol/l.Sample 2: initial result: 136 mmol/l.Repeat result: 107 mmol/l.The investigation is ongoing.
Additional Manufacturer Narrative
During the investigation, it was detected that the reference electrode housing and the reference electrode were manufactured by diamond diagnostics.The maintenance, cleaning, conditioning, calibration, and 3 levels of qc were all performed with successful results, and with no issues.The initial investigation findings suggested that the problem was consistent with the interplay between specific core components within the system (diamond diagnostic reference electrode, sodium electrode, snappak), along with potential deficiencies in the main instrument's operation.
Additional Manufacturer Narrative
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.

• 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: 22494499
• Report Number: 1823260-2025-02132
• Device Sequence Number: 19877507
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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): 11/13/2025

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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 08/22/2025; 10/22/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/13/2025; 09/18/2025; 11/13/2025
• 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