MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number	07682913001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The elecsys troponin t gen 5 reagent lot number is 88249600, and the expiration date was not provided.The alarm trace does contain a conspicuous event.There is a sample clot detection alarm on the date of the event.A field service engineer (fse) determined that the measuring cell was due for replacement, there was also a bent prewash aspiration nozzle, and an increased inside diameter of the sipper nozzle.The fse replaced the measuring cells, prewash nozzle, and the sipper nozzle.A 21-cup precision check was completed and passed.Calibration and qc were successful.It was confirmed that the customer has not had any further issues.The investigation determined that the service action resolved the issue.
Event or Problem Description
There was an allegation of a questionable elecsys troponin t gen 5 result from the cobas 8000 e 801 module for one patient.The initial result was 58 ng/l.A repeat result on another analyzer was less than or equal to 6.0 ng/l.A repeat result on another analyzer was 7.79 ng/l.The result of less than or equal to 6.0 ng/l was deemed to be correct.The questionable result was repeated because it did not match the clinical picture as well as the result from a previous sample.

• Brand Name: COBAS 8000 E 801 MODULE
• Common Device Name: IMMUNOCHEMISTRY 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: 24257149
• Report Number: 1823260-2026-00380
• Device Sequence Number: 12839513
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 07682913001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/04/2026
• 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: 64 YR
• Patient Sex: Female