MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05964067001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lithium reagent lot number was 938028.The reagent expiration date was requested, but not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the lithium assay on a cobas 8000 c 502 module.The patient had an indication of voluntary lithium administration.Testing performed on the patient on (b)(6) 2026 and approximately 10 a.M.On (b)(6) 2026 yielded high lithium values.At 3:00 p.M.On (b)(6) 2026, a sample was collected from the patient and tested, resulting in a lithium value of 0.39 mmol/l.Another sample collected from the patient at 8:00 p.M.On (b)(6) 2026 resulted in a lithium value of 1.96 mmol/l.When this value was compared to previous results, the 0.39 mmol/l result from the 3:00 p.M.Sample was then questioned.The 3:00 p.M.Sample from on (b)(6) 2026 was then repeated, resulting in a lithium value of 1.54 mmol/l with a data flag.The 3:00 p.M.Sample from on (b)(6) 2026 was repeated again on (b)(6) 2026, resulting in a lithium value of "1.70 - 1.64" mmol/l with a data flag.No specific value was provided.
Additional Manufacturer Narrative
The field service engineer replaced the wash station tubing and the sample probe.Calibrations and cuvette wash checks were performed with successful results.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 8000 COBAS C 502 MODULE
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24764510
• Report Number: 1823260-2026-01235
• Device Sequence Number: 9248766
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100853
• 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
• Report Date (Section B): 04/27/2026

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: 05964067001
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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