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	False Positive Result (1227); 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	08/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results for hepatitis b virus (hbv) testing using the kit cobas 6800/8800 mpx 480t us-ivd assay on the cobas 8800 instrument in comparison to the grifols procleix ultrio assay.On (b)(6) 2020, a sample from the patient was tested with the kit cobas 6800/8800 mpx 480t us-ivd assay and was reactive for hbv.The same sample was tested with the procleix ultrio assay and was non-reactive for all targets.Serology results for the sample were non-reactive.On (b)(6) 2020, another sample from the same patient was tested with the kit cobas 6800/8800 mpx 480t us-ivd assay and was reactive for hbv.The same sample was tested with the procleix ultrio assay and was non-reactive for all targets.Serology results for the sample were also non-reactive.The blood donation was deferred.
Additional Manufacturer Narrative
The analysis was performed on a cobas 8800 instrument (serial number: (b)(6).The investigation determined that the most likely cause of the discrepant results between the cobas mpx assay and the grifols procleix ultrio assay is the increased sensitivity of the cobas mpx assay.No data was available for review, which limited the investigation.A trend analysis could not be performed, and a definitive root cause could not be determined.The blood donation was deferred, and no further investigation was deemed necessary based on the available information.

• 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: 23073468
• Report Number: 2243471-2025-02988
• Device Sequence Number: 9996700
• Product Code: QHO
• UDI-Device Identifier: 00875197004779
• UDI-Public: 00875197004779
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/17/2025

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: 06998917190
• 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: 01/25/2021
• Initial Report FDA Received Date: 09/17/2025
• 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