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	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged a false negative result with the kit cobas 58/68/8800 hiv 192t ivd assay when tested on the cobas 5800 analyzer.The allegation involves a pregnant patient who was diagnosed as hiv antibody positive through serology testing using the geenius hiv ½ supplemental assay and hiv ab/ag screening.However, the hiv-1/hiv-2 quant assay on the cobas 5800 analyzer produced a negative result for viral load.The customer confirmed that the patient was not treated with any hiv-related medications.No harm was alleged.
Additional Manufacturer Narrative
The analysis was performed on a cobas 5800 analyzer (serial number: (b)(6).The investigation determined that the hiv-1/hiv-2 quant assay performed within specifications, and no product issue was identified.A review of the provided run data confirmed that the ct values were within expected ranges, indicating no pre-analytical errors and validating the negative result produced by the cobas 5800 analyzer.Subject matter experts suggested several possible explanations for the discrepancy between the serology and molecular test results, including the potential for the patient being an elite suppressor or a false positive serology result.Additionally, the hiv-1/hiv-2 qual assay, which uses different primers and probes, also yielded a negative result, further supporting the validity of the molecular test results.The possibility of a mutation affecting the assay was deemed unlikely given the consistent findings across multiple assays.The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress.The investigation concluded that no product issue was identified with the roche assay.

• 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: 23070665
• Report Number: 2243471-2025-02969
• Device Sequence Number: 9996615
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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: 09/30/2026
• Device Catalogue Number: 09040803190
• Device Lot Number: M23842
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 09/17/2025
• 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
• Patient Sex: Female