MAUDE Adverse Event Report: Roche Diagnostics cobas 8000 cobas c 502 module; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05964067001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with glucose hk gen.3 assay on a cobas 8000 cobas c 502 module.Initial result: 205 mg/dl.Multiple abnormal aspiration alarms prompted a repeat of the sample.No questionable result was reported outside the laboratory.Repeat result: 104 mg/dl.The repeat result was reported outside the laboratory.
Additional Manufacturer Narrative
The glucose hk gen.3 reagent lot number was 953833.The expiration date was not provided.A general reagent issue can be excluded, as no further issues were reported and a correct rerun was performed with the same reagent.The customer observed several sample short and clot alarms in parallel.The field service engineer (fse) replaced the liquid level detection circuit board (lld pcb) and the sample probe.He then verified that the test and the instrument were performing within specifications.A pcb issue can be excluded, as it was used for multiple years in a high-throughput environment and its overall consumption at a low level was stable.The service actions performed by the fse resolved the issue in a commonly trained troubleshooting process.The cause of the event was due to a component failure.

• Brand Name: cobas 8000 cobas c 502 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: 50885933
• Report Number: 1823260-2026-03939
• Device Sequence Number: 13450464
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100853
• 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: 05964067001
• 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