MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LITHIUM ELECTRODE (LI+); ION-SPECIFIC ELECTRODE TEST FOR LITHIUM

Catalog Number	03110664180
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lithium electrode lot number and expiration date were requested, but not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the lithium electrode (li+) on a 9180 electrolyte analyzer.The first sample initially resulted in a lithium value of 0.23 mmol/l and it repeated as 0.29 mmol/l.The sample was repeated on (b)(6) 2024, resulting in a value of 0.69 mmol/l.The second sample initially resulted in a lithium value of 0.53 mmol/l on (b)(6) 2024.The sample was repeated twice on (b)(6) 2024, resulting in lithium values of 1.79 mmol/l and 1.53 mmol/l.
Additional Manufacturer Narrative
It was determined that the lithium electrode was installed on the instrument on 21-oct-2023.The on-board use time for the lithium electrode is 13 weeks.The in use time for the electrode was exceeded.It was also noted that the customer did not perform regular deproteinizing of the instrument.Per product labeling: "incorrect results may lead to errors in diagnosis, posing danger to the patient.Do not use reagents or consumables that have exceeded their expiry date, otherwise you may obtain inaccurate data." the investigation did not identify a product issue.
Additional Manufacturer Narrative
G1 contact office-manufacturing site was updated.

• Brand Name: LITHIUM ELECTRODE (LI+)
• Common Device Name: ION-SPECIFIC ELECTRODE TEST FOR LITHIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18818742
• Report Number: 1823260-2024-00626
• Device Sequence Number: 4289514
• Product Code: JIH
• UDI-Device Identifier: 04015630028795
• UDI-Public: 04015630028795
• Combination Product (Y/N): Y
• Initial Reporter Country: JO
• 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
• 2 Devices were Involved in the Event: 1 2

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: 03110664180
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 03/13/2024; 10/16/2025
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/15/2024; 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