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

Catalog Number	05964067001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tina-quant albumin gen.2 results for 1 patient sample on a cobas 8000 cobas c 502 module.The initial result was 51.73 mg/dl, and the repeated result was 34.89 mg/dl.The repeated result was obtained on another module and was believed to be correct.The sample was repeated because the customer experienced issues with qc.
Additional Manufacturer Narrative
Based on the calibration data, the reagent lot number is 873067.The expiration date was not provided.The calibration and qc were acceptable.The field service representative found that the sample probe was clogged.He replaced the sample probe and performed checks and tests with acceptable results.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
• MDR Report Key: 24696983
• Report Number: 1823260-2026-01097
• Device Sequence Number: 10440090
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/26/2026
• 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