MAUDE Adverse Event Report: Roche Diagnostics cobas 8000 e 801 Module; IMMUNOCHEMISTRY ANALYZER

Catalog Number	07682913001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable elecsys total psa assay result for one patient sample tested on the cobas e 801 analytical unit.On 03-sep-2026: initial analysis yielded 21.3 ng/ml.On 07-sep-2026: repeat analysis yielded 7.26 ng/ml.Repeat analysis using a different sample tube yielded 6.94 and 7.11 ng/ml.
Additional Manufacturer Narrative
The elecsys total psa reagent lot number is 88732700.The expiration date was not provided.The field service engineer inspected the analyzer and replaced the measuring cell, sipper nozzles, and pinch valves, and performed a successful instrument check.The investigation determined the event was due to a component failure.The specific cause of the event could not be determined.The customer has not reported any other issues after the service.The investigation determined that the service actions resolved the issue.

• Brand Name: cobas 8000 e 801 Module
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50946530
• Report Number: 1823260-2026-04022
• Device Sequence Number: 10348332
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 07682913001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• 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 Sex: Male
• Patient Race: White