MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04745914001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable high sodium results from the cobas 6000 c501 module.Example 1 initial result was 174 mmol/l, and the repeat result was 140 mmol/l.Example 2 initial result was 161 mmol/l, and the repeat result was 138 mmol/l.
Additional Manufacturer Narrative
The electrode lot number and expiration date were not provided.The customer found the sipper clogged.They cleaned the sipper and performed maintenance.The field service engineer found that the naoh tubing was torn.He replaced the tubing and performed quality controls.Afterwards, no further issues were observed.The investigation determined that the service actions resolved the issue.

• Brand Name: COBAS 6000 C501 MODULE
• 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: 25260087
• Report Number: 1823260-2026-02048
• Device Sequence Number: 5419916
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/22/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/22/2026
• 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