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	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6800 serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable cobas® hiv-1 (192t) results from the cobas 6800 analyzer for six patients.Hiv viral load deviations are observed in 6 out of 50 patients who are following therapy.When tested, the patients showed higher viral loads, which are deemed incorrect due to adherence to treatment by the patient and historical patient results.The following results were observed: sample: (b)(6).Initial test: ((b)(6)2025) 402 cp/ml.Repeat test: ((b)(6)2025) target not detected.Sample: (b)(6).Initial test: ((b)(6)2025) 827 cp/ml.Repeat test: ((b)(6)2025) 169 cp/ml.Sample: (b)(6).Initial test: ((b)(6)2025) 131 cp/ml.Repeat test: ((b)(6)2025) <20 cp/ml.Sample: (b)(6).Initial test: ((b)(6)2025) 563 cp/ml.Repeat test: ((b)(6)2025) 82 cp/ml.Sample: (b)(6).Initial test: ((b)(6)2025) 1040 cp/ml.Repeat test: ((b)(6)2025) 1270 cp/ml.Sample: (b)(6).Initial test: ((b)(6)2025) 8510 cp/ml.Repeat test: ((b)(6)2025) 9090 cp/ml.
Additional Manufacturer Narrative
The investigation did not identify a product issue.Data sets were provided and reviewed.No abnormal shifts in the controls or the qs of the sample that would cause an under-quantification or over-quantification in titer were observed.Pre-analytics are important in that proper handling is needed to ensure that the white blood cells are not dispersed into the samples, so that the proviral dna is not amplified.The issue is likely related to the potential addition of proviral dna amplification during preanalytical steps.

• 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: 23097853
• Report Number: 2243471-2025-03207
• Device Sequence Number: 15607812
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 03/31/2026
• Device Catalogue Number: 09040803190
• Device Lot Number: M08892
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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