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

Catalog Number	05964067001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tina-quant igg gen2 results for 4 patient samples on a cobas 8000 cobas c 502 module.The pathologist questioned the results as they did not meet the patients' clinical pictures.On (b)(6) 2026, sample 1 had an initial result of 496 mg/dl.The sample was repeated twice and the results were 1196 mg/dl and 1267 mg/dl.The result of 1196 mg/dl was deemed correct.On (b)(6) 2026, sample 2 had an initial result of 561 mg/dl.The sample was repeated twice and the results were 1245 mg/dl and 1280 mg/dl.The result of 1245 mg/dl was deemed correct.On (b)(6) 2026, sample 3 had an initial result of 1159 mg/dl.The sample was repeated twice and the results were 2256 mg/dl and 2039 mg/dl.The result of 2256 mg/dl was deemed correct.On (b)(6) 2026, sample 4 had an initial result of 199 mg/dl.The initial result was not reported outside of the laboratory.The sample was repeated twice and the results were 499 mg/dl and 505 mg/dl.The result of 499 mg/dl was deemed correct.
Additional Manufacturer Narrative
The reagent lot number is 88498201, with an expiration date of 30-jun-2027.The field service engineer (fse) replaced the sample and reagent probes, performed software adjustments, cleaned the solenoid valves, and performed precision and qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 24897323
• Report Number: 1823260-2026-01453
• Device Sequence Number: 8640507
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: 05964067001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/16/2026
• 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: Male