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

Catalog Number	08836973190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The customer stated that the event occurred in 19 cases out of 69,079 patient samples (0.028%).The investigation determined that the specificity of negative elecsys hiv duo results, followed by polymerase chain reaction (pcr) or western blot negative confirmatory testing, is 99.97%.This rate remains within the established lower and upper confidence limits.The investigation determined that false reactive results may occur with the elecsys hiv duo assay because the specificity is less than 100%.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." "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings." the updated version of the elecsys hiv duo assay has the same specificity as the previous version (product registration 07229542190), as only the biotin intolerance was increased.The assay is performing according to specifications.The investigation did not identify a product problem.
Event or Problem Description
The initial reporter received questionable elecsys hiv duo results for 19 patient samples tested on the cobas e 801 analytical unit.The results from the analyzer were positive.The results from the center for disease control (cdc) were negative.The customer is questioning the results from the assay's new version compared to the previous one.The date of event stated in this medwatch was the date when the client started using the reagent.

• 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: 24696984
• Report Number: 1823260-2026-01095
• Device Sequence Number: 18751873
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/26/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 08836973190
• Device Lot Number: 83909201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/26/2026
• 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