MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HIV DUO; HIV DETECTION TEST

Catalog Number	08836973160
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys hiv duo and elecsys anti-hcv ii on a cobas e 801 analytical unit.This medwatch will apply to the hiv duo assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the anti-hcv assay.The sample resulted in an hiv duo value of 3.03 coi (reactive).The sample was sent to another laboratory for testing using a qualitative nucleic acid pcr test and the hiv result was "not detected".The pcr test result was deemed correct.The sample resulted in an anti-hcv value of 0.0439 coi (non-reactive).The sample was repeatedly non-reactive for anti-hcv.The patient was tested at a plasma donation center and the patient tested positive for "hepatitis".
Additional Manufacturer Narrative
Reactive samples should be repeated in duplicate with the elecsys hiv duo assay.Every repeatedly reactive result must be confirmed according to recommended confirmatory algorithms.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 23829761
• Report Number: 1823260-2025-05176
• Device Sequence Number: 9288645
• Product Code: MZF
• UDI-Device Identifier: 07613336215845
• UDI-Public: 07613336215845
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 03/31/2026
• Device Catalogue Number: 08836973160
• Device Lot Number: 80319803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/18/2026
• 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: 27 YR
• Patient Sex: Male
• Patient Weight: 95 KG