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	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the results generated for a sample tested with the kit cobas 58/68/8800 hiv 192t ivd on the cobas 6800 analyzer, comparing results from edta plasma liquid samples versus plasma separation card (psc) samples.The customer provided data for analysis, which included the following results: for sample id: (b)(6), the edta plasma liquid sample generated a titer of 881,489.1849 cp/ml.For sample id: (b)(6), the psc runs generated titers of 233,649.2329 cp/ml and 325,590.1356 cp/ml.For sample id: (b)(6), the psc runs generated a titer of 77,769.2478 cp/ml and an invalid result with error codes.Multiple qs invalids were identified in the psc runs.
Additional Manufacturer Narrative
The analysis was performed 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.Controls were reviewed and found to be normal.The data review identified multiple qs invalids in the plasma separation card (psc) runs, suggesting an issue with the samples in these runs.A potential root cause for the observed titer discrepancies may be suppression of the reactions or the presence of proviral dna in the original sample.It was noted that improper sample handling, such as delays in transferring samples after centrifugation, could contribute to proviral dna amplification and subsequent discrepancies.The customer was advised to review the psc workflow to ensure proper sample handling and to follow best practices to avoid the introduction of proviral dna.The device remains in operation 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: 23065072
• Report Number: 2243471-2025-02925
• Device Sequence Number: 10044810
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/16/2025

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: 12/31/2023
• Device Catalogue Number: 09040803190
• Device Lot Number: J04197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 09/16/2025
• 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