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	03/08/2026
Type of Reportable Event	Malfunction
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.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.No product problem was identified.
Event or Problem Description
There was an allegation of questionable elecsys hiv duo results for 3 patient samples on a cobas 8000 core unit.The customer questioned the results as the antigen results were reactive but the antibody results were negative.On (b)(6) 2026, sample 1 had an initial result of 1.98 coi, interpreted as reactive.The sample was sent to another laboratory and tested on another e801 analyzer and the result was 3.80 coi, interpreted as reactive.On (b)(6) 2026, the sample was tested on an e601 analyzer using am hiv combi pt reagent and the result was 0.463 coi, interpreted as non-reactive.The sample also underwent nucleic acid testing and was tested on a mindray analyzer and the results were negative.On (b)(6) 2026, sample 2 had an initial result of 1.18 coi, interpreted as reactive.The sample was sent to another laboratory and tested on another e801 analyzer and the result was 1.15 coi, interpreted as reactive.On (b)(6) 2026, the sample was tested on an e601 analyzer using am hiv combi pt reagent and the result was 0.306 coi, interpreted as non-reactive.The sample also underwent nucleic acid testing and was tested on a mindray analyzer and the results were negative.On (b)(6) 2026, sample 3 had an initial result of 3.26 coi, interpreted as reactive.The sample was sent to another laboratory and tested on another e801 analyzer and the result was 3.54 coi, interpreted as reactive.On (b)(6) 2026, the sample was tested on an e601 analyzer using am hiv combi pt reagent and the result was 0.286 coi, interpreted as non-reactive.The sample also underwent nucleic acid testing and was tested on a mindray analyzer and the results were 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: 24753291
• Report Number: 1823260-2026-01192
• Device Sequence Number: 18724811
• 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): 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): 04/01/2026

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: 85271501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/01/2026
• 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