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

Catalog Number	09793020001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The troponin t gen5 reagent lot number was 81185001 with an expiration date of 30-nov-2025.The customer verbally provided that the qc recovery was within the ranges.The alarm trace did not show any abnormality.The field service engineer found that the measuring cell needed replacement.He replaced the measuring cell.He then performed an instrument check, and the instrument was performing within specifications.The service actions performed by the engineer resolved the issue.No further issues were reported afterward.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys troponin t gen5 assay on a cobas pure e402 analytical unit.Sample 1: initial result: 0.06 ng/l (accompanied by a data flag).Repeat result: 36 ng/l.Sample 2: initial result: 8.52 ng/l.Repeat result: 13.8 ng/l.The emergency room questioned the initial results as they did not match the patients' previous results and requested the samples to be repeated.The samples were then repeated at a different laboratory.The repeat results were deemed to be correct.

• 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: 22165884
• Report Number: 1823260-2025-01762
• Device Sequence Number: 12719993
• Product Code: JJE
• UDI-Device Identifier: 07613336220139
• UDI-Public: 07613336220139
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 06/09/2025

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: 05/16/2025
• Initial Report FDA Received Date: 06/09/2025
• 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