MAUDE Adverse Event Report: ROCHE DIAGNOSTICS SODIUM ELECTRODE; ELECTRODE, ION SPECIFIC, SODIUM

Catalog Number	10825468001
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable sodium electrode results for 1 patient sample on a cobas 8000 ise 1800 module.The initial result was 120.7 mmol/l.The sample was repeated on another module, and the result was 136 mmol/l.This result was believed to be correct.A delta check in the customer's system prompted the sample to be repeated.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The field service representative performed checks and tests with acceptable results.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.Due to the lack of information provided, the investigation could not identify a specific cause of the event.

• Brand Name: SODIUM ELECTRODE
• Common Device Name: ELECTRODE, ION SPECIFIC, SODIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23453684
• Report Number: 1823260-2025-04465
• Device Sequence Number: 13090912
• Product Code: JGS
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 10825468001
• Device Lot Number: ASKU
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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