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	04/13/2022
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 6800/8800 mpx 480t us-ivd assay performed within specifications.No indication of an instrument or reagent malfunction was identified.A review of the alleged reagent lots (h22002 and h20248) and their performance in the field did not reveal any trends or indications of false positive results.The observed unexpected reactivity rate at the customer site was calculated to be within the clinical specificity claims.Samples with late cycle threshold (ct) values greater than 37 are near or at the limit of detection (lod) of the assay, where variation in results between reactive and non-reactive is expected due to the nature of pcr.Serology results for the alleged samples were not available for further evaluation.The investigation concluded that the questioned results did not indicate a product issue.The device remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged unexpected reactive results using the kit cobas 6800/8800 mpx 480t us-ivd assay on the cobas 6800 instrument.The customer questioned seven reactive results since (b)(6) 2020, all with late cycle threshold (ct) values greater than 37.Upon retesting, all seven samples generated non-reactive results.Serology results for the alleged samples were requested but were not available.The questioned results included four alleged false positive hiv results, one alleged false positive hepatitis b virus (hbv) result, and two alleged false positive hepatitis c virus (hcv) results.The specific samples were as follows: (b)(6) for hiv; (b)(6) for hbv; and (b)(6) for hcv.

• 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: 23099959
• Report Number: 2243471-2025-03266
• Device Sequence Number: 9226394
• 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: 08/31/2022
• Device Catalogue Number: 06998917190
• Device Lot Number: H20248
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• 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