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

Model Number	CA GEN.2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable calcium gen.2 results for 1 patient sample on a cobas 4000 c311 stand alone system.The initial result was 14.47 mg/dl, and the repeated result was 9.76 mg/dl.
Additional Manufacturer Narrative
The qc was acceptable.The calibration showed multiple "std.E" alarms for both standards for ca2, indicating issues with calibrator preparations.The field service representative replaced and adjusted the sample probe and the reagent probe.He performed checks and tests with acceptable results.The investigation determined that the service actions resolved the issue.

• 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 46250-0457
• MDR Report Key: 24764373
• Report Number: 1823260-2026-01232
• Device Sequence Number: 18681273
• 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): 05/07/2026

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 Expiration Date: 09/30/2026
• Device Model Number: CA GEN.2
• Device Catalogue Number: 04826876001
• Device Lot Number: 88236001
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/07/2026
• 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