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

Catalog Number	10825468001
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable sodium electrode results for 1 patient sample tested on a cobas c 303 analytical unit.The initial result was 160 mmo/l.The physician questioned the initial result as it was higher than the patient's history and medical condition.The sample was then repeated on a different analytical unit per the customer's routine procedures, and the repeat result was 145 mmol/l.The lower result was consistent with the patient's health.
Additional Manufacturer Narrative
The cobas c 303 analytical unit serial number was (b)(6).The visual check of the sample showed no abnormalities.The qc was acceptable.The field service engineer found that the sodium electrode was having issues.He replaced the pinch valve tubing, the sipper nozzle, the sipper tubing, the vacuum nozzle, the dilution vessel, and the sodium electrode.Reagent primes, ise checks, calibration, qc, and precision studies were performed, and they were within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
The provided alarm trace showed abnormal aspiration (sample pipetter), sample short, and sample clot detection alarms.These are indicators of possible poor sample quality.The sodium electrode was installed on (b)(6) 2026 and was reported to have 80% life left.The electrode was not due for replacement until (b)(6) 2026.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 24650528
• Report Number: 1823260-2026-01020
• Device Sequence Number: 9797396
• Product Code: JGS
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 04/23/2026

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: 07/06/2026
• Device Catalogue Number: 10825468001
• Device Lot Number: ELE62
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/23/2026
• 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