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	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two samples from the same patient tested with elecsys hiv duo on two cobas e 801 analytical units.The first sample resulted in an hiv duo value of 124 coi (reactive), with sub-results of hiv ag = 124 coi and anti-hiv = 0.152 coi when tested on the first e 801 analyzer.This sample was repeated on the first e 801 analyzer, resulting in a value of 124 coi (reactive), with sub-results of hiv ag = 124 coi and anti-hiv = 0.257 coi.Another tube of the first sample was tested in a sister laboratory on a second e 801 analyzer, resulting in an hiv duo value of 97.3 coi (reactive), with sub-results of hiv ag = 97.3 coi and anti-hiv = 0.158 coi.A third tube of the first sample was tested on the second e 801 analyzer, resulting in an hiv duo value of 88.8 coi (reactive), with sub-results of hiv ag = 88.1 coi and anti-hiv = 0.162 coi.The first sample was tested on an abbott analyzer, resulting in an hiv value of 0.23 s/co (non-reactive).The third tube of the sample was also tested on the abbott analyzer, resulting in an hiv value of 0.24 s/co (non-reactive).The pcr result for the first sample was negative.A second sample collected from the patient was tested on the first e 801 analyzer on (b)(6) 2026, resulting in an hiv duo value of 172 coi (reactive), with sub-results of hiv ag = 172 coi and anti-hiv = 0.174 coi.This sample was repeated on the abbott architect analyzer on (b)(6) 2026, resulting in an hiv value of 0.39 s/co (non-reactive).
Additional Manufacturer Narrative
The serial number of the first e 801 analyzer is (b)(6).The serial number of the second e 801 analyzer was requested, but not provided.Calibration and controls were acceptable.No instrument alarms were reported.Single false reactive results may occur in elecsys hiv duo as the labeled specificity of this assay is claimed as <100%.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 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.Elecsys hiv duo 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: 24584252
• Report Number: 1823260-2026-00886
• Device Sequence Number: 21140529
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 03/12/2026

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 Expiration Date: 08/31/2026
• 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): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/12/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NEBS/AUGMENTIN.; VITAMIN.
• Patient Age: 30 MO
• Patient Sex: Female