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	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 6800 analyzer (serial number: (b)(6)).The investigation determined that the kit cobas 58/68/8800 hiv 192t ivd assay performed within specifications.A review of the provided data, including reagent lot performance, confirmed that all controls, curves, and qs ct values were within expected ranges.No shifts or trends were observed in the reagent lot combinations, and contamination was not suspected.The root cause was attributed to pre-analytical handling issues, which can lead to the amplification of proviral dna and result in false positive outcomes.Factors such as improper sample handling, delays after centrifugation, and storage conditions were identified as potential contributors.No product-related issue was identified, and the investigation concluded that pre-analytical handling was the primary contributing factor.
Event or Problem Description
The initial reporter alleged an increase in false positive results for patient samples tested using the kit cobas 58/68/8800 hiv 192t ivd on the cobas 6800 analyzer.The allegation was based on repeat testing of patient samples, which confirmed the presence of false positive results.No additional details regarding specific test results or dates were provided.

• 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: 23075927
• Report Number: 2243471-2025-03033
• Device Sequence Number: 10064257
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: BP150262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/17/2025

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: 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: 01/24/2025
• 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: Unknown