MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (DISK SYSTEM); IMMUNOCHEMISTRY ANALYZER

Model Number	E 411
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	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The total psa reagent lot number and expiration date were not provided.The customer verbally stated that the qc was acceptable.The field service engineer (fse) found that the reagent paddle was bent.He replaced the reagent paddle.He then verified the system by checking the mixing speed.The customer performed qc with successful results.The instrument was performing within specifications.No further issues were reported after the service visit.The investigation determined that the issue found by the fse (bent reagent paddle) was the root cause of the event.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys total psa assay on a cobas e 411 analyzer (disk system), not matching the patient's previous results.The initial result was 2.19 ng/ml.The physician questioned the initial result as it did not match the patient's previous results and requested a new sample to be drawn and tested, resulting in a total psa value of 0.59 mg/ml and considered "undetectable" and below the measuring range.The original sample was then repeated, and the repeat result was <0.014 ng/ml (accompanied by a data flag).The repeat result matched the patient's previous results.An amended report with the repeat result was issued.

• Brand Name: COBAS E 411 ANALYZER (DISK SYSTEM)
• 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: 24669222
• Report Number: 1823260-2026-01042
• Device Sequence Number: 13068165
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K961481
• 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): 03/23/2026

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 Model Number: E 411
• Device Catalogue Number: 04775279001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/23/2026
• 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: 72 YR
• Patient Sex: Male