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

Catalog Number	08836973190
Medical Device Problem Codes	False Positive Result (1227); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned positive results for 1 patient sample tested for elecsys hiv duo (hiv duo) on a cobas e 801 analytical unit.The initial result was 47.7 coi (positive).The repeat result was 45.9 coi (positive).The hiv results from the abbott method were 0.07 s/co (negative) and 0.09 s/co (negative).The hiv polymerase chain reaction (pcr) result was negative.The negative results were 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: 24778880
• Report Number: 1823260-2026-01274
• Device Sequence Number: 6064319
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 05/15/2026

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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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: 34 YR
• Patient Sex: Male