MAUDE Adverse Event Report: Roche Diagnostics Sodium Electrode; electrode, ion specific, sodium

Catalog Number	10825468001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ise results from the cobas 6000 c 501 module.One example for sodium was provided.The initial result was 116 mmol/l, and the doctor questioned the result and requested repeat testing.The repeat result using an istat analyzer was 125 mmol/l.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The cobas 6000 c 501 serial number was 19b2-05.The customer changed all of the electrodes, cleaned the cups, replaced tubing and ise syringe seals, and cleaned the sipper nozzle and sample probe.For verification, ise checks, precision, and qc were performed.The investigation is ongoing.

• Brand Name: Sodium Electrode
• Common Device Name: electrode, ion specific, sodium
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50820994
• Report Number: 1823260-2026-03847
• Device Sequence Number: 21370426
• Product Code: JGS
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: k060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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 Catalogue Number: 10825468001
• Device Lot Number: GBA49
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/18/2026
• 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