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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results with multiple patient samples using the cobas® hiv-1 (192t) assay tested on the cobas 6800 instrument.The customer observed an increase in hiv-1 sample titers ranging from 20-200 copies/ml.Data provided by the customer included multiple samples generating results of "titer min" with a value of 20 copies/ml.Specific examples include: on (b)(6) 2025, 1 sample with "titer min" 20 copies/ml.On (b)(6) 2025, 3 samples with "titer min" 20 copies/ml.On (b)(6) 2025, 2 samples with "titer min" 20 copies/ml.On (b)(6) 2025, 3 samples with "titer min" 20 copies/ml.Additional samples within the data set also generated results of "titer min" with titers ranging from 20-200 copies/ml as reported by the customer.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).A review of the data provided confirmed that all controls and quality standards were valid, with normal curves and no observed shifts.The reagent lot combinations used were also confirmed to be performing as expected.The investigation identified that sample handling and workflow during pre-analytic steps likely contributed to the observed results, potentially leading to proviral dna amplification.Contamination could not be excluded as a contributing factor.The investigation did not identify a product problem.

• 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: 23058200
• Report Number: 2243471-2025-02894
• Device Sequence Number: 9226179
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/15/2025

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: 08/31/2026
• Device Catalogue Number: 09040803190
• Device Lot Number: M17416
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 09/15/2025
• 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