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 Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analysis was performed on a cobas 6800 analyzer (serial number: (b)(6)).The investigation confirmed the customer's allegation of false negative results with the kit cobas 58/68/8800 hiv 192t ivd assay.A review of the data provided for sample id (b)(6) showed a 'target not detected' result in channel 2 hiv, with flat curves confirming the result.The curves for the qs and control appeared normal and showed no signs of suppression.The likely cause of the false negative result is a mutation within the highly conserved regions of the viral genome, as described in the assay's instructions for use (ifu).Such mutations may affect primer and/or probe binding, leading to under-quantitation or failure to detect the virus.Another possibility is that the patient is an elite controller, which would require further clinical testing to confirm.A trend analysis did not identify a systemic product issue.The device remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged false negative results with the kit cobas 58/68/8800 hiv 192t ivd on the cobas 6800 instrument.The customer reported that the patient's initial screening test using an unspecified combination antibody-antigen test resulted in 61.2 s/co.Immunochromatography testing was positive for hiv-1 and negative for hiv-2.The customer repeated the test on the cobas 6800 instrument using the kit cobas 58/68/8800 hiv 192t ivd, but the result was questioned based on the initial screening result.The customer was unable to repeat the run on the cobas 6800 instrument due to insufficient patient sample.

• 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: 23100264
• Report Number: 2243471-2025-03278
• Device Sequence Number: 12904751
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/19/2025

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 Catalogue Number: 09040803190
• Device Lot Number: K00517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 09/19/2025
• 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 Age: 30 YR
• Patient Sex: Male