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	Computer Operating System Problem (2898); Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of discrepancy in the results between the cobas 5800 analyzer and the customer's lis with the cobas® hiv-1 (192t) assay.It was alleged that results with <20 cp/ml or >titer max are shown in the customer lis as tnd (non-detected).
Additional Manufacturer Narrative
Data analysis confirmed that the numeric (obx-5) field is empty, which is consistent with results that are not available or invalid for standard numeric representation.Additionally, it is confirmed that the interpretation (obx-8) field contains "bt" (below titer) or "at" (above titer).The instrument is operating as designed; the issue originated from the lis configuration, as it was monitoring only obx-5 and failed to process interpretation codes in obx-8.Modifying the configuration parameter to "verify" and instructing the lis to evaluate obx-8 resolved the misinterpretation of out-of-range results.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: 24752526
• Report Number: 2243471-2026-01185
• Device Sequence Number: 10071130
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: NU
• 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,Followup
• Report Date (Section B): 04/30/2026

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/30/2026
• 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