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

Model Number	E 411
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca 15-3 reagent information was not provided.The hiv reagent lot number is 869764.The expiration date was not provided.The field service engineer (fse) observed bubbles in the reagent due to a bent bead mixer paddle, as well as a defective pinch tube.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results for elecsys ca 15-3 ii, and elecsys hiv combi pt on a cobas e 411 analyzer (disk system).On (b)(6) 2026, the initial hiv result was 25.17 coi, interpreted as reactive the sample was repeated, and the result was 23.18 coi, interpreted as reactive.On (b)(6) 2026, a result of 4.98 coi was provided, interpreted as reactive.On (b)(6) 2026, a result from an unknown method was provided of 0.09 s/co, interpreted as non-reactive.On (b)(6) 2026, the initial ca 15-3 ii result was <1.0 u/ml.The sample was repeated twice, and the results were 138 u/ml and 32 u/ml.It is not clear if the results from each test are from one patient sample or 2 patient samples.For the hiv combi test, it is not clear if all results are from the same sample or different samples.Clarification has been requested but has not been provided.
Additional Manufacturer Narrative
The service maintenance actions performed by the fse resolved the issue.

• 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: 24793474
• Report Number: 1823260-2026-01302
• Device Sequence Number: 8805358
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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: Unknown