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

Catalog Number	05964067001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable online tdm valproic acid result from the cobas 8000 cobas c 502 module for one patient.The initial result was 0.04 g/ml, and the repeat result was 93.33 g/ml.The repeat result was deemed to be correct.The sample was repeated after the physician questioned the initial result.
Additional Manufacturer Narrative
The medwatch section d, device identification was updated.Relevant fields of sections d and g were updated.The alarm trace does not contain a conspicuous event.The calibration history provided shows instability leading up to the event.The qc data provided shows frequent outliers.A field service engineer (fse) completed maintenance actions that successfully resolved the issue, and the performance of the instrument was verified.The investigation was unable to determine a direct root cause, and no product issue was found.

• 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: 24716549
• Report Number: 1823260-2026-01146
• Device Sequence Number: 17639624
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 05/11/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 05964067001
• Device Lot Number: 88967001
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/11/2026
• 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