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	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hiv duo results from the cobas e 801 analytical unit.Patient 1: the initial result was 1.12 coi (reactive).On (b)(6) 2026, repeat testing was performed on the same sample tube, and the result was 0.239 coi (non-reactive).Two additional sample tubes drawn from the patient at the same time were tested, and the results were 0.242 coi (non-reactive) and 0.289 coi (non-reactive).Patient 2: on (b)(6) 2026, the initial result was 4.42 coi (reactive).On (b)(6) 2026, repeat testing was performed on the same sample tube, and the result was 4.50 coi (reactive).Another tube taken from this patient was tested, and the result was 0.227 coi (non-reactive).Patient 3: on (b)(6) 2026, the initial result was reactive.The repeat result from the same sample tube was non-reactive.A new sample was requested from the patient, which also yielded a non-reactive result.
Additional Manufacturer Narrative
There was an allegation of additional questionable elecsys hiv duo results from the cobas e 801 analytical unit.Patient (b)(6): on 24-mar-2026, the initial result was 1.43 coi (reactive).The repeat result was 0.229 coi (non-reactive).Patient (b)(6): on (b)(6) 2026, the initial result was 16.7 coi (reactive).The repeat result was 9.57 coi (reactive).Medwatch field b7 other relevant history: the investigation was unable to determine a specific root cause.No product issue was found.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• 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: 24638972
• Report Number: 1823260-2026-00996
• Device Sequence Number: 9918715
• 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,Followup
• 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 Expiration Date: 08/31/2026
• Device Catalogue Number: 08836973190
• Device Lot Number: 83909201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 2: CALCIO.; PATIENT 2: LOSARTAN.; PATIENT 2: METFORMINA.
• Patient Age: 20 YR
• Patient Sex: Unknown