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

Catalog Number	08836973190
Medical Device Problem Codes	False Positive Result (1227); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable positive results for 2 patient samples tested for elecsys hiv duo (hiv duo) on a cobas e801 analyzer.Patient 1 result from the e801 analyzer was 1.67 coi (positive).The sub results of the assay were hivag 0.196 coi and ahiv 1.67 coi.The hiv result from the mindray method was 0.52 s/co (negative).On (b)(6) 2026, patient 2 result from the e801 analyzer was 16.4 coi (positive).The sub results of the assay were hivag 0.184 coi and ahiv 16.4 coi.The sample was repeated by the abbott method with an hiv result of 0.08 s/co (negative).No repeat testing on the e801 analyzer and no confirmatory testing (pcr or western blot) was performed for either patient.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).Calibration was acceptable.False reactive results may occur with the elecsys hiv duo assay as the specificity is less than 100%.Product labeling states: "all initially reactive samples should be retested 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 supplementary algorithms.The subresults for either hivagb or ahivb can be used as an aid in the selection of the confirmation algorithm for reactive samples." for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The elecsys hiv duo assay performs within specification.

• 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: 24840238
• Report Number: 1823260-2026-01394
• Device Sequence Number: 6145612
• 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): 04/10/2026

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: 05/31/2026
• Device Catalogue Number: 08836973190
• Device Lot Number: 81244701
• 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: 04/10/2026
• 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: 24 YR
• Patient Sex: Male