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

Catalog Number	10825468001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The customer noted that "abnormal aspiration" alarms had occurred.The field service representative found an issue with the ise (ion-selective electrode) sipper nozzle.He replaced the sipper nozzle and cleaned the valve, which resolved the issue.He performed checks and tests with acceptable results.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable sodium electrode results for 1 patient sample on a cobas pro ise analytical unit.The initial result was 138 mmol/l.The sample was repeated on another module, and the results were 132 mmol/l and 132 mmol/l.The sample was repeated because the initial high result was questioned.The repeated result was believed to be correct.

• 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: 23416800
• Report Number: 1823260-2025-04412
• Device Sequence Number: 10407877
• Product Code: JGS
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 10/29/2025

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 Expiration Date: 04/19/2026
• Device Catalogue Number: 10825468001
• Device Lot Number: DVN84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2025
• Initial Report FDA Received Date: 10/29/2025
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Weight: 71 KG