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	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hiv duo results for 1 patient on a cobas e 801 analytical unit compared to an abbott alinity analyzer.The initial result was 4.21 coi (reactive).A second sample was collected from the patient and the result was 3.87 coi (reactive).The first sample was repeated and the result was 4.47 coi (reactive).A patient sample was tested on an abbott alinity analyzer and the result was negative.A pcr test was also performed and the result was negative.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).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.Confirmatory tests include western blot and hiv rna tests.The investigation did not identify a product problem.The root cause of the event could not be determined.The elecsys hiv duo assay performs within specification.False reactive results may occur in elecsys hiv duo as the labeled specificity of this assay is less than 100%.

• 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: 25257322
• Report Number: 1823260-2026-02032
• Device Sequence Number: 18777053
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BP190403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 05/22/2026

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/22/2026
• 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