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	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred 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.A review of the provided data confirmed that control values were consistent with release specifications, and no suppression of the qs curves or abnormalities in ct values were observed.Result discrepancies at the lower end of the linear range were attributed to potential amplification of proviral dna, which can occur due to improper pre-analytical handling of samples.Factors such as delayed processing after centrifugation, temperature fluctuations, or improper pipetting near the buffy coat may contribute to such discrepancies.The customer reported implementing changes to their centrifugation process, resulting in improved separation and reproducibility.No product-related issue was identified, and the investigation concluded that the observed discrepancies were likely due to pre-analytical handling variability.The device remains in use at the customer site.
Event or Problem Description
The initial reporter alleged result discrepancies in viral load for patient samples tested using the kit cobas 58/68/8800 hiv 192t ivd on the cobas 6800 analyzer.The customer reported non-reproducible results for the same patient across different sample collections.For sample id (b)(6) (first collection on (b)(6) 2023), the following results were reported: batch 234 yielded 273 cp/ml, batch 252 yielded a negative result, batch 262 yielded 112 cp/ml, and batch 262 (repeated) yielded 88 cp/ml.For sample id (b)(6) (second collection on (b)(6) 2023), the following results were reported: batch 254 yielded 135 cp/ml, batch 262 yielded a negative result, and batch 262 (repeated) yielded 115 cp/ml.The customer used plasma samples stored at -20°c and vortexed for 20 seconds after thawing.The results were not reproducible across different reagent lots and testing batches.

• 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: 23088931
• Report Number: 2243471-2025-03146
• Device Sequence Number: 9710610
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/18/2025

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: 02/29/2024
• Device Catalogue Number: 09040803190
• Device Lot Number: J08460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 09/18/2025
• 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