MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 402 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	09793020001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results for multiple assays from the cobas pure e 402 analytical unit.Only data for one sample for vitamin b12 was provided.The initial result was 1149 pg/ml, and the repeat result was 555 pg/ml.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The reagent lot number was 893080.The expiration date was not provided.The field service engineer found an issue with the blank cell calibration.He performed a full system check, including all probe/nozzle adjustments, rinse station volume adjustments, mixing paddle adjustments, measuring cell magnet adjustment, and cleaning the probes and nozzles.He replaced the measuring cell, deleted the calibration history, and performed initial blank cell calibration.Diagnostic checks were successful.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined that the service actions resolved the issue.

• Brand Name: COBAS E 402 ANALYTICAL UNIT
• 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: 24575809
• Report Number: 1823260-2026-00866
• Device Sequence Number: 18725754
• Product Code: JJE
• UDI-Device Identifier: 07613336220139
• UDI-Public: 07613336220139
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• 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): 03/30/2026

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: 09793020001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 84 KG