MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® HIV-1 (192T); HUMAN IMMUNODEFICIENCY VIRUS (HIV) VIRAL LOAD MONITORING TEST

Catalog Number	09040803190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6800 serial number was (b)(6).The investigation indicated no product-related issues were identified.The issue is sample-related and it is known that the hiv-1 quantitative test is cross-reactive with the car-t therapies as the vector used contains the hiv-1 target.This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of hiv-1 infected patients.
Event or Problem Description
There was an allegation of discrepant cobas® hiv-1 (192t) results from the cobas 6800 analyzer for a single patient.On (b)(6) 2025, the initial sample generated the following results: hiv titer4.20e+2cp/ml sample diluted flag.Hiv-1/2-ak+p24-ag negative.On (b)(6) 2025, the sample was repeated and generated the following results: hiv titer 7.17e+001 cp/ml.Hiv-1/2-ak+p24-ag negative.On (b)(6) 2025: an independent new draw in another laboratory was performed and with the hologic test generated the following results: hiv-1/2 screening (eclia): negative.Hiv-rna (tma): not detectable.

• Brand Name: COBAS® HIV-1 (192T)
• Common Device Name: HUMAN IMMUNODEFICIENCY VIRUS (HIV) VIRAL LOAD MONITORING TEST
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 22982331
• Report Number: 2243471-2025-02766
• Device Sequence Number: 9370971
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BP150262
• 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): 09/05/2025

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: 03/31/2026
• Device Catalogue Number: 09040803190
• Device Lot Number: M08892
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/05/2025
• 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: BREYANZI
• Patient Sex: Unknown