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

Model Number	E 411
Medical Device Problem Codes	False Positive Result (1227); 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 hiv combi pt reagent lot number was 869764 with an expiration date of 30-nov-2026.The calibration and qc were within the ranges.The field service engineer found that the microbead mixer was bent, causing bubbles inside the reagent.He also found that the pinch tube had a hole and the mixing speed was higher than recommended.He replaced the bead mixer and the pinch tube and fixed the mixing speed.The specificity of elecsys hiv combi pt is less than 100% per the labeled specificity claim of the elecsys hiv combi pt assay, and therefore, false reactive results may occur.The product labeling states: "initially reactive or borderline samples giving cutoff index values of = 0.9 in either of the redetermination's are considered repeatedly reactive.Repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.Confirmatory tests include western blot and hiv rna tests." the product labeling also states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the elecsys hiv combi pt assay performs within specification.The investigation determined that the event was consistent with an issue with the bead mixer and pinch tube.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys hiv combi pt assay on a cobas e 411 analyzer (disk system).The initial result was 23.18 coi.The 1st repeat result was 25.17 coi.On (b)(6) 2026: the 2nd repeat result was 4.98 coi.The sample was repeated on the chemiluminescent microparticle immunoassay (cmia) platform, and the 3rd repeat result was 0.09 s/co (non-reactive).The sample was then tested for hiv-1 viral load polymerase chain reaction (pcr), and the result was "not detected".

• 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: 24778131
• Report Number: 1823260-2026-01239
• Device Sequence Number: 9935343
• 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): 05/28/2026

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: 05/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/28/2026
• 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