MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 4000 C311 STAND ALONE SYSTEM; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04826876001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and expiration date were not provided.The field service engineer fse checked and verified the tubings of the cell-rinse unit, adjusted the cell rinse levels, and cleaned the cell rinse nozzles.The investigaiton determined that the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable hemoglobin a1c results using hemolyzing reagent (for whole blood and hemolysate hba1c) reagent on the cobas 4000 c311 stand alone system.Patient 1 initial result was 9.2%, and the repeat result was 5.9 %.Patient 2 initial result was 10.7%, and the repeat result was 6.7%.

• Brand Name: COBAS 4000 C311 STAND ALONE SYSTEM
• 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: 24544774
• Report Number: 1823260-2026-00819
• Device Sequence Number: 5688999
• Product Code: JJE
• UDI-Device Identifier: 04015630925551
• UDI-Public: 04015630925551
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 04826876001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/09/2026
• 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