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	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode serial number and expiration date were not provided.The field service engineer (fse) inspected the module and found damaged rinse tubing and splashes on the reaction cells.He replaced the rinse tubing assembly, reaction cells, reagent and sample probe rinse stations; cleaned the ion-selective electrode bath, decontaminated the reference lines; adjusted the gear pump pressure; verified the sample and reagent probe alignments; and performed a system reset, air purges, incubator water bath exchange, cell blank measurements, mechanism checks, photometer checks, ion-selective electrode checks, calibrations, qcs, and patient correlation studies.The investigation determined that a leakage or seal issue caused the event.The customer did not report 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 ion-selective electrode (ise) and other assay results from patient samples tested on the cobas 6000 c501 module.One example of discrepant results was provided: sodium the initial result was 254.0 mmol/l.The repeat result was 138.0 mmol/l.The reporter deemed the initial result unreliable, prompting the rerun.

• 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: 25591624
• Report Number: 1823260-2026-02477
• Device Sequence Number: 5442647
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 06/23/2026

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: 06/01/2026
• Initial Report FDA Received Date: 06/23/2026
• 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