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	09/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analysis was performed on a cobas 8800 analyzer (serial number: (b)(6)).The investigation determined that the cobas mpx assay performed within specifications.No evidence of hardware issues or reagent-related contributions was identified.A review of the provided run data confirmed the questioned hbv reactive result (sample id (b)(6)) with a cycle threshold (ct) value of 35.6.The amplification curve was sigmoidal and robust.No other hbv-reactive samples were present on the same plate, and all run controls were valid, indicating no issues during sample preparation or amplification/detection.Plate position analysis did not suggest cross-contamination from neighboring samples.A definitive root cause for the discrepant result could not be determined.Potential causes include a true positive result due to pre-analytical contamination or a false negative serology result.Further testing, such as anti-hbc testing or donor follow-up, may help clarify the result.The device remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged a discrepant result with the kit cobas 6800/8800 mpx 480t us-ivd assay on the cobas 8800 instrument.The allegation involved a sample (id 9908345) that was reactive for hepatitis b virus (hbv) using the cobas mpx assay with a cycle threshold (ct) value of 35.6.The amplification curve for the hbv result was described as sigmoidal and robust.However, the corresponding serology result for the same sample was negative, leading the customer to classify the result as discrepant.The sample was part of a run batch (5302) that included 35 samples and 4 run controls.No other hbv-reactive samples were present on the same plate, except for one hiv-reactive sample (id 9908337).All run controls were valid and showed expected results.Blood was not reported to have been released, and no harm was alleged in this case.

• 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: 23100139
• Report Number: 2243471-2025-03280
• Device Sequence Number: 15759298
• Product Code: QHO
• UDI-Device Identifier: 00875197004779
• UDI-Public: 00875197004779
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 10/05/2022
• 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