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	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of false-positive elecsys hiv duo results for 1 patient on a cobas e 801 analytical unit.The initial elecsys hiv duo result was 100 coi (reactive); the anti-hiv result was 0.0855 coi (non-reactive), and the hiv ag result was 100 coi (reactive).On (b)(6) 2026, the repeated elecsys hiv duo result was 89.7 coi (reactive); the anti-hiv result was 0.0850 coi (non-reactive), and the hiv ag result was 89.7 coi (reactive).On (b)(6) 2026, the repeated elecsys hiv duo result was 89.8 coi (reactive); the anti-hiv result was 0.0778 coi (non-reactive), and the hiv ag result was 89.8 coi (reactive).It was reported that a rapid hiv test was performed on this patient, yielding a negative result.A viral load hiv test was also conducted, and the result was undetectable.The testing methods were not provided.It was reported that the patient's medical history for (b)(6) 2025 showed a reactive elecsys hiv duo result that entered the diagnostic algorithm with the same findings: an undetectable viral load and a negative rapid test.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration and qc were acceptable.Single false reactive results may occur as the specificity of elecsys hiv duo is less than 100%.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.

• 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: 25082968
• Report Number: 1823260-2026-01743
• Device Sequence Number: 18775829
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/05/2026

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: 83909202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/05/2026
• 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 Age: 79 YR
• Patient Sex: Male