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

Catalog Number	08836973190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The expiration date of the elecsys hiv duo reagent lot number 888322 was not provided.The cobas e 801 analytical unit serial number was (b)(6).The calibration on (b)(6) 2026 was acceptable.The qc was within the ranges.The product labeling states: "reactive in the elecsys hiv duo assay.All initially reactive samples should be redetermined in duplicate with the elecsys hiv duo assay.Redetermination of samples with an initial coi = 1.00 can be performed automatically." the product labeling also states: "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 product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.The elecsys hiv duo assay performs within specifications.The cause of the event was consistent with a preanalytic issue (contamination during sample collection) at the customer site.Preanalytics are within the customer's responsibility.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys hiv duo assay on a cobas e 801 analytical unit.Elecsys hiv duo (ahiv sub-results) all results in coi sample 1: initial result: 3.89 coi.1st repeat result: 1.70 coi.On (b)(6) 2026: 2nd repeat result: 9.18 coi.3rd repeat result: 9.20 coi (lot: 888322) all the results were obtained using the lot number 910947, except for the 3rd repeat result, which was obtained using the lot number 888322.Sample 2: initial result: 37.8 coi.1st repeat result: 19.6 coi.On (b)(6) 2026: 2nd repeat result: 180 coi.3rd repeat result: 183 coi.All the results were obtained using the lot number 910947.Sample 1 and sample 2 were then repeated using the tubes that were sent to the chemistry area, and the results were negative.The negative results were consistent with the patients' clinical pictures.

• 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: 24893537
• Report Number: 1823260-2026-01446
• Device Sequence Number: 21307022
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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
• Report Date (Section B): 04/16/2026

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: 08836973190
• Device Lot Number: 91094701, 888322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/16/2026
• 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