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

Catalog Number	08836973162
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hiv duo reagent expiration date was not provided.The cobas e 801 analytical unit serial number was (b)(6).The field service engineer performed preventive maintenance on the system, an instrument check, and a mechanical check with successful results.He then verified that the system was performing within specifications.The instrument was back in operation.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 8 patients' samples tested with elecsys hiv duo assays on a cobas e 801 analytical unit.Sample 1 and sample 2 were: initially tested for hiv on abbott alinity, and the results were negative.Elecsys hiv duo results: positive.Geenius hiv ½ confirmatory test result: negative.Sample 3, sample 4, sample 5, sample 6, sample 7, and sample 8 were: elecsys hiv duo results: positive.Geenius hiv ½ confirmatory test results: negative.
Additional Manufacturer Narrative
The field service engineer found no cause for the event and verified the instrument's performance.Per the labeled specificity claim of the assay: single false positive results can occur with the elecsys hiv duo assay.No further issues were reported after the service visit.The investigation did not identify a 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: 24379356
• Report Number: 1823260-2026-00574
• Device Sequence Number: 13391474
• Product Code: MZF
• UDI-Device Identifier: 07613336183120
• UDI-Public: 07613336183120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/08/2026

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 Catalogue Number: 08836973162
• Device Lot Number: 852759
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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 Sex: Unknown