MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® HIV-1/HIV-2 QUALITATIVE; LAB-BASED HIV NAT DIAGNOSTIC AND/OR SUPPLEMENTAL TEST

Catalog Number	09040528190
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 8800 analyzer (serial number: (b)(6)).The investigation was limited due to the unavailability of additional information or data regarding the alleged samples.Based on the limited investigation performed, there is no indication that the kit c58/68/88 hiv-1/hiv-2 qual 192t ivd assay is not performing as intended.The discrepancy is likely attributable to site- or sample-specific factors, such as sample swap, contamination, or differences in technology.A definitive root cause for the reported event could not be determined.
Event or Problem Description
The initial reporter alleged five discrepant results when testing with the kit c58/68/88 hiv-1/hiv-2 qual 192t ivd assay on the cobas 8800 system.Three of the samples were plasma preparation tubes (ppt), and two were plasma samples.One of the five discrepant results involved a known high-titer hiv patient sample tested as part of a validation process, which yielded a negative result.The same sample was also tested on a hologic platform; however, the results of this test are not known.

• Brand Name: COBAS® HIV-1/HIV-2 QUALITATIVE
• Common Device Name: LAB-BASED HIV NAT DIAGNOSTIC AND/OR SUPPLEMENTAL 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: 23085584
• Report Number: 2243471-2025-03116
• Device Sequence Number: 13259331
• Product Code: QST
• UDI-Device Identifier: 00875197006384
• UDI-Public: 00875197006384
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: BP190360/10
• 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
• 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 Catalogue Number: 09040528190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• 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