MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® HCV (192T); ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMP.FOR DETECTION OF HCV RNA,HCV

Catalog Number	09040765190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable false positive cobas® hcv (192t) results for 2 patient plasma samples tested on the cobas 8800 analyzer.Patient 1 initial result was 2.27e+001 iu/ml (hcv detected).On (b)(6) 2024, the repeat result from a new sample collected (b)(6) 202 was target not detected.On (b)(6) 2024, a new sample was collected and antibody testing for hcv was negative.Patient 2 initial result was 3.30e+001 iu/ml (hcv detected).On (b)(6) 2024, a new sample was collected and antibody testing for hcv was negative.On (b)(6) 2024, a new sample was collected and antibody testing for hcv was negative.On (b)(6) 2024, the repeat result from a new sample collected (b)(6) 2024 was target not detected.The results were reported as indeterminate.
Additional Manufacturer Narrative
The cobas 8800 serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.This issue was consistent with contamination inadvertently introduced during sample handling or patients with an early acute hcv infection that may be undetected by serology.

• Brand Name: COBAS® HCV (192T)
• Common Device Name: ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMP.FOR DETECTION OF HCV 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: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 20580028
• Report Number: 2243471-2024-03155
• Device Sequence Number: 18166704
• Product Code: MZP
• UDI-Device Identifier: 00875197006391
• UDI-Public: 00875197006391
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150015
• 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): 11/08/2024

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: 09/30/2025
• Device Catalogue Number: 09040765190
• Device Lot Number: K21418
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/08/2024
• 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