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	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of e801 #1 is (b)(6) and the serial number of e801 #2 is (b)(6).The serial number for e801 #3 was requested, but not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for 11 patient samples tested with elecsys hiv duo.The samples were tested on one of three cobas e 801 analytical unit analyzers, e801 #1, e801 #2, and e801 #3.E801 #3 is located at a second site.Please refer to the attachment for all patient data.The results measured with the elecsys hiv duo assay did not match results obtained with the abbott architect i2000 method and the bio-rad geenius method.A doctor at the facility indicated they are trying to switch from the abbott method to the roche method, but the correlations keep failing.Samples recovering values near the cutoff are showing up reactive with the roche method and negative with the abbott method.
Additional Manufacturer Narrative
For sample id (b)(6), the specific abbott architect result was 0.08 coi (non-reactive).For sample id (b)(6), the specific abbott architect result was 0.11 coi (non-reactive).The elecsys hiv duo result for this sample was reactive.
Additional Manufacturer Narrative
The provided calibration and quality control data was acceptable.The patient samples were provided for investigation.Sample ids (b)(6) were found reactive with elecsys hiv duo.Further clarification was not possible due to insufficient sample volume.Sample ids (b)(6) were confirmed false reactive in the anti-hiv module of the elecsys hiv duo assay.Sample id (b)(6) was found to be negative in elecsys hiv duo.Sample id (b)(6) was determined to be true positive for anti hiv-1.Testing of a new sample from this patient is highly recommended.Sample ids (b)(6) were confirmed false reactive in the hiv ag module of the elecsys hiv duo assay.False positive results can occur per the assay specificity documented in product labeling.The investigation did not identify a product issue.

• 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: 22915926
• Report Number: 1823260-2025-02655
• Device Sequence Number: 15932636
• Product Code: MZF
• UDI-Device Identifier: 07613336215845
• UDI-Public: 07613336215845
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,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 Expiration Date: 09/30/2025
• Device Catalogue Number: 08836973160
• Device Lot Number: 76496002
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 12/12/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/05/2025; 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: 66 YR
• Patient Sex: Male