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	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 303 analyzer is (b)(6).The field service engineer ran precision studies and these recovered within guidelines.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the potassium electrode on a cobas c 303 analytical unit.The first sample initially resulted in a potassium value of 6.2 mmol/l.The value was deemed critical and did not agree with the patient's clinical status, so the sample was repeated.The repeat result was 3.8 mmol/l and this value was deemed correct.The sample was repeated five additional times, each time resulting in a value of 3.8 mmol/l.On an unknown date in the fall of 2025, a second patient sample initially resulted in a potassium value of 9.0 mmol/l and it repeated as 4.2 mmol/l.No questionable results were reported outside of the laboratory for this sample.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• 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 46250-0457
• MDR Report Key: 24616178
• Report Number: 1823260-2026-00940
• Device Sequence Number: 18600423
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/17/2026

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
• Device Lot Number: ASKU
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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