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	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure e 402 analytical unit serial number was (b)(6).The investigation was unable to determine a specific root cause.The elecsys hiv duo assay performed within specification.Per product for the assay: all initially reactive samples should be redetermined 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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.
Event or Problem Description
There was an allegation of questionable elecsys hiv duo results from the cobas pure e 402 analytical unit.The initial results were 40.9 coi and 40.4 coi (reactive).On (b)(6) 2026 and (b)(6) 2026, the sample was tested at another laboratory for confirmation using an alinity analyzer, and the results were 0.16 coi, 0.15 coi, 0.14 coi, and 0.13 coi (non-reactive).The questionable results were not reported outside of the laboratory.

• 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: 24846650
• Report Number: 1823260-2026-01395
• Device Sequence Number: 8926977
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 04/10/2026

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: 852715
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/11/2026
• 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