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

Catalog Number	08836973160
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hiv duo results for 2 patient serum samples on a cobas e 801 analytical unit.On (b)(6) 2025, sample 1 had initial hiv results of 2.160 coi, 2.150 coi, and 2.170 coi, all interpreted as reactive.On (b)(6) 2025, sample 2 had initial hiv results of 34.80 coi, 36.0 coi, and 35.0 coi, all interpreted as reactive.The patients' doctor questioned the results as they were both taking pre-exposure prophylaxis hiv medication.Both samples were sent out for pcr confirmatory testing per internal protocol and both sample results were determined to be not detected.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2025.The qc recovery data provided was acceptable.The alarm trace showed procell short alarms.The field service engineer (fse) found an issue with the measuring cell and replaced it.A blank cell test, instrument check, calibration, and qc were performed successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 23073464
• Report Number: 1823260-2025-02989
• Device Sequence Number: 15951645
• Product Code: MZF
• UDI-Device Identifier: 07613336215845
• UDI-Public: 07613336215845
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 08836973160
• Device Lot Number: 839092
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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: PRE-EXPOSURE PROPHYLAXIS HIV MEDICATION.
• Patient Age: 38 YR
• Patient Sex: Male