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	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sodium electrode serial number is (b)(6), with an expiration date of 08-sep-2026.The ise indirect na-k-cl for gen.2 electrode serial number is fbt71, with an expiration date of 14-jul-2026.The alarm trace showed ion-selective electrode (ise) noise errors, multiple ise calibration errors, and abnormal aspiration (an indicator of possible poor sample quality) errors.The field service engineer inspected the analyzer and found the vacuum nozzle clogged with a clot or foreign substance.He cleaned the vacuum nozzle, dilution cup, ise, and dilution nozzles, and sipper nozzle, and tightened a loose fitting on an ise reagent cap.He verified the analyzer's performance by ise checks, calibrations, qcs, and precision testing.The investigation determined that the issue found by the fse was the root cause of the event.The customer has not reported any other issues after the service.The investigation determined that the service actions resolved the issue.
Event or Problem Description
The initial reporter received questionable sodium electrode and ise indirect na-k-cl for gen.2 assay results for four patient samples tested on the cobas c 303 analytical unit.The following are examples of patient samples identified to have discrepant results from the list provided: patient sample 1 sodium the initial result of the initial patient sample was 156.1 mmol/l.The provider questioned the initial result.The initial result of a recollected patient sample was 140.1 mmol/l.The repeat result of the initial patient sample was 141.3 mmol/l.The repeat result of the recollected patient sample was 141.3 mmol/l.Patient sample 2 sodium the initial result from the analyzer was 165.6 mmol/l.The repeat result from another c 303 analyzer was 140.1 mmol/l.Chloride the initial result from the analyzer was 121.3 mmol/l.The repeat result from another c 303 analyzer was 106.4 mmol/l.The repeat results were deemed correct.

• 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: 24910898
• Report Number: 1823260-2026-01473
• Device Sequence Number: 9799995
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial 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