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	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable cobas® hiv-1 (192t) results with 3 patient samples tested on the cobas 6800 analyzer.It was reported that the customer was performing a lot to lot comparison and repeated 3 samples that were initially tested with a previous lot, n09424, and then with lot p03576.Sample 1: on (b)(6) 2026, the initial result was 9.21e+01 iu/ml using lot n09424.On (b)(6) 2026, the repeat result was 2.17e+01 iu/ml using lot p03576 on (b)(6) 2026, the repeat result was 2.74e+01 iu/ml using lot p03576.Sample 2: on (b)(6) 2026, the initial result was 3.86e+01 iu/ml using lot n09424.On (b)(6) 2026, the repeat result was negative using lot p03576.Sample 3: on (b)(6) 2026, the initial result was negative using lot n09424.On (b)(6) 2026, the repeat result was negative using lot p03576.On (b)(6) 2026, the repeat result was

• 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 ; +1(925)353-4412
• MDR Report Key: 50882035
• Report Number: 2243471-2026-03929
• Device Sequence Number: 9826576
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BP150262
• 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
• 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: 09040803190
• Device Lot Number: P03576
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/04/2026
• Initial 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: Unknown