MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05964067001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c502 module serial number was (b)(6).The field service engineer (fse) replaced rinse tubing, valves for the rinse probes, gear head pump and vacuum valves.The sample arm with sample probe, reagent probe, and probe rinse were adjusted.The customer has added an additional wash and has had no further issues.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned low results for multiple patient samples tested for urea/bun on a cobas 8000 cobas c 502 module.Discrepant results were provided for 1 patient sample.The initial result was 9.7 mmol/l.The repeat result was 14.4 mmol/l.The sample was repeated on a different c502 module with a result of 14.6 mmol/l.
Additional Manufacturer Narrative
Section d, device identification, was updated.Relevant fields of sections d and g were updated.The urea/bun reagent lot number and expiration date were not provided.The instrument was checked, and carryover checks were performed.There were many abnormal aspiration and sample short alarms before and after the date of the event.As multiple service actions were performed, the specific cause of the event could not be determined.The investigation determined that the service actions resolved the issue.

• 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 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 46250-0457
• MDR Report Key: 24626248
• Report Number: 1823260-2026-00968
• Device Sequence Number: 9068641
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K100853
• 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,Followup
• Report Date (Section B): 04/20/2026

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
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/20/2026
• 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: Female