MAUDE Adverse Event Report: Roche Molecular Systems, Inc. - Branchburg cobas® HIV-1/HIV-2 Qualitative (192T); Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

Catalog Number	09040528190
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction

• Brand Name: cobas® HIV-1/HIV-2 Qualitative (192T)
• Common Device Name: Lab-Based Hiv Nat Diagnostic And/Or Supplemental 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 ; +1(925)353-4412
• MDR Report Key: 50219809
• Report Number: 2243471-2026-03291
• Device Sequence Number: 16096539
• Product Code: QST
• UDI-Device Identifier: 00875197006384
• UDI-Public: 00875197006384
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BP190360/10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 09040528190
• Device Lot Number: N12045
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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: Male