MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The roche 9180 sodium electrode lot number is 31244847.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 using an old reference electrode with a non-roche reference electrode housing was 93.000 mmol/l.The repeat result using a new reference electrode with a non-roche reference electrode housing was 142.000 mmol/l.Patient sample 2: the high result was 113.000 mmol/l.The low result was 102.000 mmol/l.The questionable results were not reported outside the laboratory.
Additional Manufacturer Narrative
In the initial mdr, h11 additional narrative update: the roche 9180 sodium electrode expiration date is 30-may-2025.The investigation included a review of the data set provided by the customer: the sodium electrode calibration for one standard is above the range.The qc results were within the specified ranges.The field service engineer inspected the analyzer and replaced the reference housing and reference electrode.The investigation determined that the event was consistent with the interplay between specific core components within the system (non-roche reference electrode, sodium electrode, and system reagents).The investigation determined that the service actions resolved the issue.
Additional Manufacturer Narrative
On 17-jul-2025, the customer reported additional questionable roche 9180 sodium electrode results from two patient samples tested on the electrolyte analyzer w/o starterkit 9180.On 26-may-2025: patient sample (b)(6) the initial result was 100 mmol/l with a data flag.The first repeat result was 111 mmol/l with a data flag.The second repeat result was 100 mmol/l with a data flag.Patient sample (b)(6) the initial result was 102 mmol/l with a data flag.The first repeat result was 113 mmol/l with a data flag.
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 analyzers.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: 22306541
• Report Number: 1823260-2025-01909
• Device Sequence Number: 7997741
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 11/06/2025

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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 09/11/2025; 10/22/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/13/2025; 10/03/2025; 11/06/2025
• 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