MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 SODIUM ELECTRODE; ION SPECIFIC SODIUM ELECTRODE

Catalog Number	03110419180
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number was 31243247 with an install before date of 04-apr-2025.The electrodes were requested for investigation; however, they were discarded by the customer and are no longer available.The field application specialist (fas) indicated that the instrument is working fine with new reference electrodes.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant low results for 1 patient sample tested for sodium (na) on a (b)(6) electrolyte analyzer.The initial result was 109 mmol/l with a data flag.The customer performed cleaning and conditioning and the repeat result was 138 mmol/l.The customer repeated the sample and the result was again 109 mmol/l.No questionable results were reported outside of the laboratory.The result of 138 mmol/l was believed to be correct based on the patient¿s previous results.
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The 9180 electrolyte analyzer serial number was (b)(6).Calibration and qc were acceptable.Trending was performed on this type of complaint and no abnormal trend was identified.The issue was resolved by replacing the reference electrode.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
G1 contact office-manufacturing site was updated.

• Brand Name: ROCHE 9180 SODIUM ELECTRODE
• Common Device Name: ION SPECIFIC SODIUM ELECTRODE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): AVL SCIENTIFIC CORP.; 33 mansell court; roswell GA 30076
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 21344710
• Report Number: 1823260-2025-00383
• Device Sequence Number: 8912291
• Product Code: JGS
• UDI-Device Identifier: 04015630028702
• UDI-Public: 04015630028702
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K961458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

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: 04/04/2025
• Device Catalogue Number: 03110419180
• Device Lot Number: 31243247
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 10/16/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/14/2025; 10/31/2025
• 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 Sex: Unknown