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 Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged the generation of multiple questioned results during routine testing with the kit cobas 58/68/8800 hiv 192t ivd assay on the cobas 6800 platform.The allegation involved ten samples with initially positive results that showed significantly decreased viral loads upon retesting.Specific data included: sample id (b)(6): initial titer 256 (tested (b)(6)2023), retest titer 112 (tested (b)(6)2023).Sample id (b)(6): initial titer 240 (tested (b)(6)2023), retest tnd (tested (b)(6)2023).Sample id (b)(6): initial titer 1284 (tested (b)(6)2023), retest titer <20 (tested (b)(6)2023).Sample id (b)(6): initial titer 426 (tested (b)(6)2023), retest titer 112 (tested (b)(6)2023).Sample id (b)(6): initial titer 846 (tested (b)(6)2023), retest titer 260 (tested (b)(6)2023).Sample id (b)(6): initial titer 397 (tested (b)(6)2023), retest titer 241 (tested (b)(6)2023).Sample id (b)(6): initial titer 430 (tested (b)(6)2023), retest titer 31.6 (tested (b)(6)2023).Sample id (b)(6): initial titer 500 (tested (b)(6)2023), retest titer 174 (tested (b)(6)2023).Sample id (b)(6): initial titer 518 (tested (b)(6)2023), retest titer 238 (tested (b)(6)2023).Sample id (b)(6): initial titer 230 (tested (b)(6)2023), retest titer <20 (tested (b)(6)2023).
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, and no systemic issue was identified with the reagent kit lot j21286.The observed discrepancies in viral load results were attributed to sample-specific factors, including issues related to sample quality, handling, transport, and storage.The customer's workflow, including variations in centrifugation practices and potential pre-analytical factors, was noted as a possible contributor to the observed results.Additionally, the cloudy appearance of plasma upon arrival at the molecular lab suggests potential sample quality concerns.A definitive root cause for the reported discrepancies could not be determined based on the available information.The device and assay remain in use at the customer site.

• 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: 23089373
• Report Number: 2243471-2025-03157
• Device Sequence Number: 9682720
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 09/18/2025

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: 03/31/2024
• Device Catalogue Number: 09040803190
• Device Lot Number: J21286
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 09/18/2025
• 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