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

Catalog Number	08836973160
Medical Device Problem Codes	False Positive Result (1227); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable false positive elecsys hiv duo result from the cobas e 801 analytical unit for one patient.The initial result was reactive, and also reactive twice with the eflow.The sample was sent out for confirmation testing, and the result was negative for antibodies.The customer sent the sample out for ribonucleic acid (rna) testing, and it was determined to be non-reactive.All of the results were reported in real-time; however, they waited for all of the results to be completed before acting on the results.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).A field service engineer (fse) verified the rinse levels and inspected the probes and sipper nozzles; no issues were found.The fse completed an instrument check, and the results were passing.The investigation is ongoing.
Additional Manufacturer Narrative
The alarm trace report contains alarms for the following: sample clot detection, sample foam detection, abnormal aspiration (sample pipetter s1), sample probe: abnormal aspiration, and sample short errors.These are consistent with possible poor sample quality.The sample was confirmed to be a false positive following confirmatory testing.Per product labeling, "repeatedly reactive samples must be confirmed according to cdc recommended confirmatory algorithms.The subresults for either hivag or ahiv can be used as an aid in the selection of the confirmation algorithm for reactive samples." the investigation did not find a general product problem.

• 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: 23594741
• Report Number: 1823260-2025-04713
• Device Sequence Number: 9577721
• Product Code: MZF
• UDI-Device Identifier: 07613336215845
• UDI-Public: 07613336215845
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/18/2025

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: 852715
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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
• Patient Age: 19 YR
• Patient Sex: Female