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	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e602 module serial number was (b)(6).The e601 module serial number was not provided.The particular patient sample showed false positive results confirmed by nat testing.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." the investigation did not identify a product problem.
Event or Problem Description
The initial reporter questioned positive results for 1 patient tested for elecsys hiv combi pt (hiv combi) and elecsys hiv duo (hiv duo) on a cobas e 602 module and a cobas e 601 module.This medwatch will cover hiv duo.Refer to medwatch with a1 patient identifier (b)(6) for information on the hiv combi results.The initial hiv combi result was 120 coi (positive).The repeat result was 104 coi (positive).On (b)(6) 2026, a new sample was obtained, and the hiv combi result was 140 coi (positive).The customer performed additional hiv testing using autobio point of care testing (poct) chemiluminescence immunoassay (clia) with a result of 0.059 coi (negative) and daan nucleic acid testing (nat) with a result of < 125 copies/ml (negative).One of the samples was recentrifuged and repeated.It is not clear if this was the original sample or the 2nd sample.The hiv combi results were 117 coi (positive) and 103 coi (positive).The hiv duo result was 120 coi (positive).No questionable results were reported outside of the laboratory.

• 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: 24681633
• Report Number: 1823260-2026-01059
• Device Sequence Number: 9854901
• 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): 03/24/2026

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: ASKU
• 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: 03/24/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OMEPRAZOLE
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Race: Asian