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

Catalog Number	09793194001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sodium electrode lot number was fue72, with an expiration date of 15-dec-2026.Calibration data showed stability.Quality control data showed frequent outliers and systematic shifts.The field service engineer cleaned the dilution vessel, vacuum nozzle, and vacuum tubing.The sodium electrode was replaced.Ise checks, calibration, controls, and precision studies were run.The investigation determined the issue was resolved by the service actions.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the sodium electrode on a cobas c 303 analytical unit.A doctor questioned the initial results.The initial results also failed laboratory delta checks.The samples were repeated on a second analyzer and these values were deemed correct.The first patient sample initially resulted in a sodium value of 139.5 mmol/l and it repeated as 129.9 mmol/l.The second patient sample initially resulted in a sodium value of 162.2 mmol/l and it repeated as 152.8 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: 25456473
• Report Number: 1823260-2026-02286
• Device Sequence Number: 15641861
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 05/26/2026
• Initial Report FDA Received Date: 06/10/2026
• 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 Age: 44 YR
• Patient Sex: Female