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	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of falsely reactive elecsys hiv duo results for several patient samples tested on the cobas e 801 analytical unit.The customer stated that they have identified several weakly reactive elecsys hiv duo results (1.01-8.6 coi), predominantly in pregnant women, which were non-reactive when verified with an alternative immunochromatographic method.The customer provided two patient samples with allegedly false reactive results.The patient samples were further tested using western blot (recommended confirmatory test for the elecsys hiv duo).Patient sample 1: in the patient's first trimester of pregnancy, the result was 3.28 coi (reactive).In the patient's second trimester, the result was 2.85 coi (reactive).The result of the western blot confirmatory test was "non-reactive".Patient sample 2: in the patient's first trimester of pregnancy, the result was 3.18 coi (reactive).In the patient's second trimester, the result was 3.94 coi (reactive).The patient had a pregnancy loss, and the result of the patient's 2026 first quarterly check-in was 2.83 coi (reactive).The result of the western blot confirmatory test was "non-reactive".
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation reviewed the qc results; the results are within the specified ranges.The investigation determined that false-reactive results may occur with the elecsys hiv duo assay because its specificity is less than 100%, and that the customer followed the required steps as stated in the assay's method sheet.Product labeling states: "interpretation of the results.Numeric result - one or both of the duplicate retests have a coi = 1.00.Result message - repeatedly reactive.Interpretation/further steps - 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." the elecsys hiv duo assay is performing according to specifications.

• 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: 24956656
• Report Number: 1823260-2026-01545
• Device Sequence Number: 9890501
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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): 04/22/2026

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: 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: 03/31/2026
• Initial Report FDA Received Date: 04/22/2026
• 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