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	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of false-positive elecsys hiv duo results for 2 patients on a cobas e 801 analytical unit.It was alleged that both patients had persistent reactive elecsys hiv duo results over several years.Patient 1: the patient's hiv duo result was 44.3 coi on (b)(6) 2023, 15.9 coi on (b)(6) 2025, and 19.7 coi on (b)(6) 2026.Patient 2: the patient's hiv duo result was 46.5 coi on (b)(6) 2024, 44.5 coi on (b)(6) 2024, and 25.9 coi on (b)(6) 2025.Both patients consistently showed reactive results for antigen (hiv ag), but non-reactive for antibody (anti-hiv).Repeat testing on the cobas e801 confirmed these results (numerical repeat results were not provided).Patient 1: the patient's hiv ag result was 44.3 coi on (b)(6) 2023, 15.9 coi on (b)(6) 2025, and 19.7 coi on (b)(6) 2026.Patient 1: the patient's anti-hiv result was 0.085 coi on (b)(6) 2023, 0.101 coi on (b)(6) 2025, and 0.099 coi on (b)(6) 2026.Patient 2: the patient's hiv ag result was 46.5 coi on (b)(6) 2024, 44.5 coi on (b)(6) 2024, and 25.9 coi on (b)(6) 2025.Patient 2: the patient's anti-hiv result was 0.091 coi on (b)(6) 2024, 0.083 coi on (b)(6) 2024, and 0.082 coi on (b)(6) 2025.Both patients were tested using other manufacturer platforms (mindray and maccura, using total hiv kits); the results were non-reactive.Numerical results were not provided.Nucleic acid testing (polymerase chain reaction) was performed, and both patients tested negative all 3 times.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).Single false reactive results may occur as the specificity of elecsys hiv duo is less than 100%.Product labeling states: "all initially reactive samples (results = 1.0 coi) should be re-determined in duplicate with the elecsys hiv duo assay.Repeatedly reactive samples must be confirmed according to cdc-recommended confirmatory algorithms." 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 duo assay performs within specification.

• 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: 24550946
• Report Number: 1823260-2026-00824
• Device Sequence Number: 21178686
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/09/2026

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: 02/12/2026
• Initial Report FDA Received Date: 03/09/2026
• 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: 26 YR
• Patient Sex: Unknown