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

Catalog Number	04826876001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The crep2 reagent lot number was 91574601 with an expiration date of 31-jul-2026.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for creatinine plus ver.2 (crep2) on a cobas 4000 c311 stand alone system.The initial result was 1.58 mg/dl.On (b)(6) 2026, the repeat result was 0.84 mg/dl.On (b)(6) 2026, a new sample was obtained, and the result was 0.88 mg/dl.
Additional Manufacturer Narrative
The photometer lamp and cuvettes were exchanged on (b)(6) 2026.The customer cleaned the sample and reagent probes regularly.The alarm trace provided for 09-mar-2026 did not show any abnormalities.A general reagent or analyzer issue can be excluded since the calibration and qc were acceptable, and instrument performance testing was within specifications.The investigation did not identify a product problem.Based on the provided sample pictures, the cause of the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.

• 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: 24779464
• Report Number: 1823260-2026-01282
• Device Sequence Number: 9935391
• 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,Followup
• Report Date (Section B): 05/15/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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