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	10/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 5800 analyzer (serial number: (b)(6).The investigation determined that the observed differences in hiv titers between the cobas 5800 and cobas 4800 analyzers were likely due to small shifts in the target pcr curves, while the internal control and quality standards remained stable.No product issue was identified with the cobas 5800 reagent kit lot h24934.Potential contributing factors for the observed discrepancies include reagent kit lot variability, instrument-to-instrument variance, and sample handling or storage conditions, such as freezing and evaporation.These factors may have led to cumulative log titer shifts within expected ranges for both platforms.The investigation concluded that the cobas 5800 analyzer and associated reagents were performing within specifications.The device remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged discrepant results were generated during verification analysis of the kit cobas 58/68/8800 hiv 192t ivd on the cobas 5800 analyzer when compared to results previously obtained on the cobas 4800 analyzer.The customer performed testing on 21 patient plasma samples.The samples were collected in gel tubes, plasma was separated, and the samples were stored at -25°c and -20°c.The samples were frozen once prior to measurement on the cobas 4800 analyzer in (b)(6) 2022 and a second time prior to measurement on the cobas 5800 analyzer in (b)(6) 2022.Testing was conducted three times as part of the verification process.Two of the 21 sample results for hiv were questioned.For sample id (b)(6), testing on the cobas 5800 analyzer on (b)(6) 2022 generated an hiv titer of 20 cp/ml.Retesting on (b)(6) 2022 generated an hiv titer of 52.2 cp/ml.The hiv titer previously generated on the cobas 4800 analyzer was 72.5 cp/ml.For sample id (b)(6), testing on the cobas 5800 analyzer on (b)(6) 2022 generated an hiv titer of 7031.3 cp/ml.Retesting on (b)(6) 2022 generated an hiv titer of 10181.7 cp/ml.The hiv titer previously generated on the cobas 4800 analyzer was 20600 cp/ml.

• 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: 23067274
• Report Number: 2243471-2025-02945
• Device Sequence Number: 21252827
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: 07/31/2023
• Device Catalogue Number: 09040803190
• Device Lot Number: H24934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• 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