MAUDE Adverse Event Report: Roche Diagnostics cobas 6000 c501 module; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04745914001
Medical Device Problem Codes	Mechanical Problem (1384); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant sodium electrode results for 1 patient sample tested on a cobas 6000 c501 module.Initial result: 197 mmol/l.During the validation process, the customer noticed that the initial result was elevated, prompting a repeat of the sample.Repeat result: 138 mmol/l.The repeat result was considered correct.No questionable result was reported outside the laboratory.
Additional Manufacturer Narrative
The sodium electrode lot number and expiration date were not provided.The field service engineer (fse) found that the aspiration tubing in the wash chamber was partially torn at the vacuum vessel, causing sporadic dripping from the needle into random cuvettes.He replaced the wash station tubing set.The fse performed test runs with successful results.He then verified that the instrument was performing within specifications.The investigation is ongoing.

• Brand Name: cobas 6000 c501 module
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50896429
• Report Number: 1823260-2026-03947
• Device Sequence Number: 5828858
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• 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