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	02/05/2026
Type of Reportable Event	Malfunction
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: the initial result was 1.36 coi.On (b)(6) 2026, the sample was repeated in a different laboratory using 2 different methods (abbott alinity hiv combo and biorad genscreen ultra hiv ag/ab), and the repeat results were both negative.Patient 2: on (b)(6) 2026: the initial result was 2.71 coi.On (b)(6) 2026: the repeat result was 2.48 coi.The sample was also repeated in a different laboratory using 2 different methods (abbott alinity hiv combo and biorad genscreen ultra hiv ag/ab), and the repeat results were both negative.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The provided data showed the calibration on (b)(6) 2026, and it was within the expected ranges.The qc was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
False reactive results may occur in elecsys hiv duo as the specificity of the assay is less than 100% per the labeled specificity claim of the assay.The product labeling states: "all initially reactive samples should be redetermined in duplicate with the elecsys hiv duo assay." the product labeling also states: "repeatedly reactive samples must be confirmed according to cdc recommended confirmatory algorithms." and 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.

• 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: 24579502
• Report Number: 1823260-2026-00878
• Device Sequence Number: 18449778
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• 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,Followup
• Report Date (Section B): 04/03/2026

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: 839092
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White