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	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 402 analyzer is (b)(6).Calibration data was acceptable.The field service engineer checked the analyzer.The mixer, reagent, and sample pipettes were inspected.The pre-wash system was checked.The pipette lines and pre-wash lines were cleaned.Mechanism checks were performed and dripping was observed in the aspiration line.A valve was replaced and another valve was disassembled, cleaned, and inspected.The dripping was resolved.The system lines were purged and mechanism checks were performed.The customer confirmed that the analyzer was working without errors.All initially reactive samples (results = 1.0 coi) should be re-determined in duplicate with the elecsys hiv duo assay.Repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.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.
Event or Problem Description
The initial reporter stated they received questionable positive results for one patient sample tested with elecsys hiv duo on a cobas pure e 402 analytical unit.No questionable results were reported outside of the laboratory.The sample initially resulted in an hiv duo value of 15.5 coi (reactive).The sample was repeated, resulting in an hiv duo value of 14.2 coi (reactive).The sample was repeated again on (b)(6) 2026, resulting in an hiv duo value of 14.7 coi (reactive), with an anti-hiv sub-result of 14.7 coi (reactive) and an hiv ag sub-result of 0.204 coi (non-reactive).The sample was sent to other laboratories using unknown methods and the hiv results were 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: 25152496
• Report Number: 1823260-2026-01867
• Device Sequence Number: 10757155
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/12/2026

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: 852715
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/12/2026
• 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: 70 YR
• Patient Sex: Male