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	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bicarbonate liquid reagent lot number was 92066901 with an expiration date of 30-jan-2027.The calibration and qc were acceptable.The alarm trace showed abnormal aspiration (sample pipetter) and sample short alarms.These are indicators of possible poor sample quality.The field service engineer (fse) found that the vacuum tubing was torn and the rinse water level for the cuvettes was low.He trimmed and reattached the vacuum tubing to rinse nozzles, adjusted the gear pump, and adjusted the rinse water level for the cuvettes.He then performed mechanical checks and precision studies, and they were within specifications.The fse verified that the instrument was performing within specifications.The service actions performed by the fse resolved the issue.No further issues were reported after the service visit.The cause of the event was related to a hardware issue.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with bicarbonate liquid assay on a cobas c 303 analytical unit.Initial result: 36 mmol/l.The initial result did not match teh patient's clinical picture, prompting the repeat of the sample.No questionable result was reported outside the laboratory.Repeat result: 24 mmol/l.The repeat result was deemed to be 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: 25126559
• Report Number: 1823260-2026-01815
• Device Sequence Number: 20997863
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/08/2026

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: 04/17/2026
• Initial Report FDA Received Date: 05/08/2026
• 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