MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HIV DUO; HIV DETECTION TEST

Catalog Number	08836973190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)( the calibration was within the expected ranges.The qc provided from 09-dec-2025 to 10-apr-2026 was acceptable.Per the labeled specificity claim of the assay: single false positive results can occur with the elecsys hiv duo assay.The product labeling states: "reactive in the elecsys hiv duo assay.All initially reactive samples should be redetermined in duplicate with the elecsys hiv duo assay.Redetermination of samples with an initial coi = 1.00 can be performed automatically." the product labeling also states: "repeatedly reactive samples must be confirmed according to cdc recommended confirmatory algorithms." the product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.The elecsys hiv duo assay performs within specifications.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys hiv duo assay on a cobas e 801 analytical unit.Patient 1: initial result: 442 coi.1st repeat result: 448 coi.2nd repeat result: 442 coi.Western blot test result: negative.3rd repeat result: negative when tested on an abbott analyzer.On (b)(6) 2026, a new sample was drawn from the patient and tested on a cobas e 801 at a different hospital, and the results were 312 coi, 319 coi, and 310 coi.Patient 2 was tested on (b)(6)2026: initial result: 97.30 coi.1st repeat result: 97.0 coi.2nd repeat result: 94.90 coi.Western blot test result: negative.

• Brand Name: ELECSYS HIV DUO
• Common Device Name: HIV DETECTION TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24971200
• Report Number: 1823260-2026-01572
• Device Sequence Number: 16066179
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: BP190403
• 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
• Report Date (Section B): 04/23/2026

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 Catalogue Number: 08836973190
• Device Lot Number: 910947
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/23/2026
• 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 Sex: Male