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	04/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable sodium electrode and ise indirect na-k-cl for gen.2 assay results from 13 patient samples tested on the cobas c 303 analytical unit.The following are the patient samples identified to have discrepant results from the list provided: on (b)(6) 2026: patient sample 1 the initial sodium result from the analyzer was 148.4 mmol/l.The repeat result from another cobas analyzer was 139.9 mmol/l.Patient sample 2 the initial sodium result from the analyzer was 146.2 mmol/l.The repeat result from another cobas analyzer was 138.2 mmol/l.On (b)(6) 2026: patient sample 3 the initial chloride result from the analyzer was 102.2 mmol/l.The repeat result from another cobas analyzer was 90.7 mmol/l.The initial results were deemed high and were questioned by the doctors, prompting the rerun.The repeat results were deemed correct.
Additional Manufacturer Narrative
The initial sodium electrod serial number is (b)(6).The initial ise indirect na-k-cl for gen.2 electrode serial number is (b)(6).The expiration dates were not provided.The field service engineer inspected the analyzer and determined that debris accumulation and physical damage to the ion-selective electrode (ise) dilution cup caused the event.He replaced the dilution cup, cleaned the sipper nozzle, aspirate/dispense nozzles, and vacuum nozzles.He performed successful hardware and ise checks.The customer performed successful calibrations and qcs.The investigation determined that the damaged ise dilution cup caused the event.The investigation determined that the service actions resolved the issue.

• 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: 25092576
• Report Number: 1823260-2026-01752
• Device Sequence Number: 5079310
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/06/2026

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: 04/13/2026
• Initial Report FDA Received Date: 05/06/2026
• 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