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	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation reviewed the data set provided by the customer: the calibration results are within the specified ranges.The qc results are within the specified ranges.The preanalytical data do not indicate any issues.Product labeling states: "interpretation of the results.Numeric result - coi >/= 1.00.Result message - reactive.Interpretation/further steps - 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." "repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.Confirmatory tests include western blot and hiv rna tests.For the right choice of method: the module-specific subresult for hivag and ahiv can be used." "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings." the cause of the event could not be determined.The assay is performing according to specifications.
Event or Problem Description
The initial reporter received a questionable elecsys hiv duo result for one serum sample tested on the cobas e 801 analytical unit.On (b)(6)-2026: the initial result of the patient's serum sample from the analyzer was 32.0 coi (reactive).On (b)(6) 2026: the initial result of the patient's plasma sample from the advia centaur analyzer was <0.05 index (non-reactive).The repeat result from the advia centaur analyzer was 0.204 index (non-reactive).The repeat result of the patient's plasma sample from the analyzer was 0.232 coi (non-reactive).The repeat result of the patient's serum sample from an alinity analyzer was "negative".

• 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: 24902506
• Report Number: 1823260-2026-01449
• Device Sequence Number: 18617216
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: 910947
• 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 Age: 39 YR
• Patient Sex: Female