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

Catalog Number	04826876001
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 83940601 with an expiration date of 31-jul-2026.Calibration and qc data around the time of the event have been reviewed and are inconspicuous and within acceptable ranges, respectively.Therefore, a general reagent/instrument issue can be excluded.The field service engineer (fse) found that an expired reagent (a1cd2) was used, and the operator maintenance was not performed.The fse changed the reagent, performed preventative maintenance activities, decontaminated the sample probe, replaced the reaction cells and halogen lamp, and cleaned the water path.The fse then performed a new calibration, qc run, and hardware check with acceptable results.The module was confirmed to be running back in specification.The investigation determined that the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application result for a patient sample tested on a cobas 4000 c311 stand alone system.The initial result was 10.07%.The repeat result was 5% on another platform (tosoh g8).(b)(6) 2025: a new sample was obtained and repeated on the c311 and the result was 10.08%.It was indicated that the repeat result of 5% was more compatible with the patient's history.
Additional Manufacturer Narrative
The investigation determined the issue was likely related to the operator.The reagent and system were not processed correctly.Maintenance actions were not performed properly by the operator.Additionally, a sample mismatch was suspected as the operator does not have a barcode system and manually identified the sample, which likely led to human error.

• 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: 23780457
• Report Number: 1823260-2025-05062
• Device Sequence Number: 10105607
• Product Code: JJE
• UDI-Device Identifier: 04015630925551
• UDI-Public: 04015630925551
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Followup
• Report Date (Section B): 12/22/2025

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 Catalogue Number: 04826876001
• 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: 11/16/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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