MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® FACTOR II AND FACTOR V TEST; TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR

Catalog Number	07948352190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable result with the cobas® factor ii and factor v test for a patient sample tested on a cobas z 480 analyzer.On (b)(6) 2025, the initial result was het f2 (heterozygous).On (b)(6) 2025, a second draw was tested and the result was wt f2 (wild type).On (b)(6) 2025, the repeat result of the original sample was het f2.On (b)(6) 2025, the original sample, the second draw, and another draw sample were tested on another instrument and the results were het f2, all three times.
Additional Manufacturer Narrative
A review of the data confirmed that the factor ii and factor v positive control and negative controls were valid in all runs, indicating the assay is working as intended.No instrument-related issue was identified.The investigation determined that the discrepant results between heterozygous and wild-type f2 are likely related to a sample/patient-specific issue.Based on multiple tests, the result for wild-type f2 appears to be an outlier.No product problem was identified.

• Brand Name: COBAS® FACTOR II AND FACTOR V TEST
• Common Device Name: TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR
• 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: 23977741
• Report Number: 2243471-2026-00061
• Device Sequence Number: 21508845
• Product Code: NPQ
• UDI-Device Identifier: 00875197005998
• UDI-Public: 00875197005998
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172913
• 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,Followup
• Report Date (Section B): 01/29/2026

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: 07948352190
• Device Lot Number: N08958
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/29/2026
• 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