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	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number was fft21.The expiration date was not provided.An "abnormal aspiration (sample pipetter)" alarm was observed on the alarm trace data.The field service engineer (fse) did not find a cause for the event.The fse replaced the seals, decontaminated and flushed the flowpath, replaced the sipper and pinch tube, reseated the electrodes, and performed instrument checks.The customer performed calibration and qc with acceptable results.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter complained of calibration issues, qc issues, and discrepant results for 2 patient samples tested for electrode, sodium (na) on a cobas pure sample supply unit.Patient 1 initial result was 153 mmol/l.The repeat result was 146 mmol/l.Patient 2 initial result was 149 mmol/l.The repeat result was 143 mmol/l.

• 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: 25353891
• Report Number: 1823260-2026-02143
• Device Sequence Number: 10743646
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 05/11/2026
• Initial Report FDA Received Date: 06/01/2026
• 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