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

Catalog Number	04826876001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The triglycerides reagent lot number was 916901 with an expiration date of 31-oct-2026 based on the provided data, a general reagent problem can be excluded because the qc results were acceptable.The field service engineer (fse) performed a full-path chlorine decontamination for the system, replaced both the reagent and sample probes, and readjusted all needles.He also replaced the wash station tubing, the degasser, and calibrated the volumes.He also performed preventive maintenance as a proactive measure.The service actions performed by the fse resolved the issue.No further issues have been observed since the service visit.The specific cause of the event could not be determined.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with triglycerides assay on a cobas 4000 c311 stand alone system.Patient 1: initial result: 700 mg/dl.Repeat result: 100 mg/dl.Patient 2: initial result: 100 mg/dl a new sample was drawn and tested, resulting in a triglycerides value of 200 mg/dl.The customer performed repeatability tests using different control materials and noted that while 20 repetition times obtained similar results, the repetition for the 21st time obtained a very high value.No exact values were provided.

• 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: 24714610
• Report Number: 1823260-2026-01126
• Device Sequence Number: 14974314
• Product Code: JJE
• UDI-Device Identifier: 04015630925551
• UDI-Public: 04015630925551
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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): 03/27/2026

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: 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: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• 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