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

Catalog Number	04745914001
Medical Device Problem Codes	Off-Label Use (1494); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode serial number and expiration date were not provided.The investigation determined that the customer had not replaced the electrodes since (b)(6) 2025.Product labeling states: "on-board stability after installation, the electrode is stable for the following time period: 2 months or 9000 tests, whichever comes first.The electrodes should be replaced after this time period has expired.For replacement refer to instructions in the operator¿s manual of the applicable analyzers.The field service engineer inspected the module and found blood and crystals on top of the cuvettes, dirt near the sipper, a cut tube in the rinse unit, and a misplaced rinse pin preventing proper cuvette washing.He performed maintenance and repairs to resolve these issues.The investigation determined that the customer's off-label use and leakage/seal in the analyzer caused 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 assay results for one patient sample tested on the cobas 6000 c501 module.The initial result is 181 mmol/l.The repeat result is 147 mmol/l.The repeat result is 140 mmol/l.The questionable result was not reported outside the laboratory, as it was deemed high and incompatible with the patient's clinical data.

• 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: 25147042
• Report Number: 1823260-2026-01857
• Device Sequence Number: 21520090
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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): 05/12/2026

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: 04/20/2026
• Initial Report FDA Received Date: 05/12/2026
• 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