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

Catalog Number	04745914001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable glucose hk gen.3 assay results for two patient samples tested on the cobas 6000 c501 module.One patient sample was identified with discrepant results from the data provided: initial analysis of the patient sample yielded 7.8 mg/dl.Repeat analysis on another c 501 module yielded 180 mg/dl.Repeat analysis on another c 501 module yielded 180 mg/dl.The initial result was not reported outside the laboratory.
Additional Manufacturer Narrative
The glucose hk gen.3 reagent lot number is 936950.The expiration date was not provided.The field service engineer inspected the module and replaced the sample probe, cells, and lamp.He verified that the assay and module were performing according to specifications.The investigation determined that a component failure had caused the event.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 -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: 50882974
• Report Number: 1823260-2026-03934
• Device Sequence Number: 9827067
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 09/24/2026

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: 09/02/2026
• Initial Report FDA Received Date: 09/24/2026
• 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