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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pro ise analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned the results for multiple patient samples tested on a cobas pro ise analytical unit.Approximately 200 patient samples were repeated, and 70 corrected reports were issued.Discrepant results were provided for 2 patient samples tested for sodium electrode (na).Patient 1 initial result was 140 meq/l.The repeat result was 132.6 meq/l.Patient 2 initial result was 141 meq/l.The repeat result was 134.3 meq/l.The high results were questioned, and the samples were repeated on a different cobas pro ise analyzer.The repeat results were believed to be correct.
Additional Manufacturer Narrative
Calibration and qc were acceptable.The customer used a centrifugation time of 5 minutes at "4150." based on the sample tubes used, this spin time is shorter than recommended (10 minutes), and the spin speed may be faster than recommended.The field service engineer (fse) observed the instrument operating properly.The customer complained of no further issues, and no additional information was provided.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: 23920792
• Report Number: 1823260-2025-05361
• Device Sequence Number: 15659699
• Product Code: JGS
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/25/2026

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: 08/15/2026
• Device Catalogue Number: 10825468001
• Device Lot Number: EUF19
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/25/2026
• 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