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	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 303 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable sodium electrode results from the cobas c 303 analytical unit for ten patients.Results were provided for two patients.Patient 1's initial result was 129.8 mmol/l.The repeat result on another analyzer was 135 mmol/l.Patient 2's initial result was 133 mmol/l.The repeat result on another analyzer was 140 mmol/l.The initial results were questioned by the customer when they noticed that there was a discrepancy in the sodium results between the two analyzers.No questionable results were released outside of the laboratory.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
Medwatch field d device identification d4 serial no was updated.Qc and calibration were passing at the time of the event.A field service engineer (fse) determined that a poor calibration resulted in questionable results.The fse performed an ion-selective electrode (ise) recalibration and performed a 21-cup precision check with acceptable results.The customer has not reported any additional issues since the service was completed.The investigation determined that the service actions resolved the issue.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: 24270474
• Report Number: 1823260-2026-00408
• Device Sequence Number: 10658697
• Product Code: JGS
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 03/16/2026

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/21/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/16/2026
• 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