MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS PURE SAMPLE SUPPLY UNIT

Catalog Number	09793178001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 303 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the sodium electrode on a cobas c 303 analytical unit.The sample initially resulted in a sodium value of 125 mmol/l.The result did not match the patient's history, so the sample was repeated on a second analyzer.The repeat result was 133 mmol/l and was deemed correct.
Additional Manufacturer Narrative
The field service engineer noticed the electrode required additional conditioning.To address the issue, the engineer ran wash maintenance on the analyzer.An ise check, calibration, and controls were run.The patient samples were re-tested on two different analyzers to ensure the results were accurate.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS PURE SAMPLE SUPPLY UNIT
• Common Device Name: SAMPLE SUPPLY UNIT
• 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 46250-0457
• MDR Report Key: 24077913
• Report Number: 1823260-2026-00182
• Device Sequence Number: 21253731
• Product Code: JJE
• UDI-Device Identifier: 07613336220146
• UDI-Public: 07613336220146
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 02/20/2026

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: 09793178001
• Device Lot Number: ECA18
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/20/2026
• 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: 64 YR
• Patient Sex: Female