MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 303 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	09793194001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sodium electrode serial number is (b)(6).The expiration date was not provided.The alarm trace contains an "abnormal aspiration (sample pipetter)".This is an indicator of possible poor sample quality.The field service engineer (fse) identified an issue with the sample probe.The fse replaced the sample probe, the sipper nozzle, the vacuum nozzle, and the dilution cup.Precision, qc, and patient correlation testing were all acceptable.The customer did not report any other issues after the service.The investigation determined that the issue found by the fse was the root cause of the event.
Event or Problem Description
We received an allegation of questionable sodium electrode assay results for multiple patient samples tested on the cobas c 303 analytical unit.One patient sample with discrepant results was provided: the initial result from the analyzer is 142 mmol/l.The repeat result from a cobas pro ise is 128 mmol/l.The repeat result was deemed correct.

• Brand Name: COBAS C 303 ANALYTICAL UNIT
• 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: 24536476
• Report Number: 1823260-2026-00807
• Device Sequence Number: 10343354
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 09793194001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/06/2026
• 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