MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV REAGENT KIT; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Catalog Number	01L79-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An abstract by t.Bui-bullock, a.P.Brown, m.Brown, s.Lawless, b.Roemmich, n.W.Anderson, and c.W.Farnsworth ¿comparison of the elecsys hcv duo assay to standard of care algorithmic testing¿, clinical chemistry 70:s1 (2024) noted false negative architect anti-hcv results on five patients that were positive by the elecsys hcv duo assay and hcv-rna testing.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation was performed for false nonreactive results with the architect anti-hcv assay (lot# unknown) which included a review of data and information provided in the article, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause list number and complaint issue.Labeling review concluded that the issue is adequately addressed.Based on our investigation, no systemic issue or product deficiency of the architect anti-hcv reagent was identified.
Event or Problem Description
An abstract by t.Bui-bullock, a.P.Brown, m.Brown, s.Lawless, b.Roemmich, n.W.Anderson, and c.W.Farnsworth ¿comparison of the elecsys hcv duo assay to standard of care algorithmic testing¿, clinical chemistry 70:s1 (2024) noted false negative architect anti-hcv results on five patients that were positive by the elecsys hcv duo assay and hcv-rna testing.No impact to patient management was reported.

• Brand Name: ARCHITECT ANTI-HCV REAGENT KIT
• Common Device Name: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21177755
• Report Number: 3002809144-2025-00013
• Device Sequence Number: 8602911
• Product Code: MZO
• UDI-Device Identifier: 00380740001414
• UDI-Public: (01)00380740001414
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P050042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: 01L79-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/01/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR MOD, 01L86-01, SN# UNKNOWN; ARC I1000SR MOD, 01L86-01, SN# UNKNOWN
• Patient Sex: Unknown