MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® MPX MULTIPLEX HIV, HCV & HBV NUCLEIC ACID TEST; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV

Catalog Number	06998917190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged a questionable result with the kit cobas 6800/8800 mpx 480t us-ivd assay on the cobas 6800 instrument.A plasma sample initially generated a reactive hiv result with a non-sigmoidal curve and a late cycle threshold (ct) value of 36.75.Upon retesting, the sample was mistakenly processed as a serum sample, and the result was non-reactive.No additional testing results, such as serology, were available.
Additional Manufacturer Narrative
The analysis was performed on a cobas 6800 analyzer (serial number: (b)(6)).The investigation determined that the cobas mpx assay performed within specifications, and no hardware issues were identified during the analysis of the provided run data.The internal control (ic) of both the initial and retest runs did not exhibit suppressed growth curves, which would indicate the presence of pcr inhibitors.The retest was conducted with the plasma sample mistakenly processed as a serum sample, which constitutes off-label use.However, the differences in pipetting settings between plasma and serum processing are minor and are not expected to impact the final result.Additionally, the instrument software would flag and invalidate any incorrectly pipetted samples during the sample preparation process.A definitive root cause for the questioned result could not be determined.However, a likely explanation is that the sample had a low viral load near or at the limit of detection (lod), which could result in variability between reactive and non-reactive results upon retesting.Minor sample contamination as the source of the hiv rna could not be excluded.No trends were identified for the associated lot (h30627).The device remains in operation at the customer site.

• Brand Name: COBAS® MPX MULTIPLEX HIV, HCV & HBV NUCLEIC ACID TEST
• Common Device Name: HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV
• 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: 23099976
• Report Number: 2243471-2025-03270
• Device Sequence Number: 18478450
• Product Code: QHO
• UDI-Device Identifier: 00875197004779
• UDI-Public: 00875197004779
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BL125576
• 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): 09/19/2025

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: 03/31/2023
• Device Catalogue Number: 06998917190
• Device Lot Number: H30627
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 09/19/2025
• 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