MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ANTI-HCV

Catalog Number 06C37-27

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6c37 that has a similar product distributed in the us, list number 1l79.

Event Description

The customer observed (b)(6) results while using architect anti-hcv reagents.The following data was provided.Patient 1 : initial (b)(6), not repeated.A new specimen was drawn approximately 2 weeks later and was also (b)(6) using the architect method (b)(6).Other methods were (b)(6) for both specimens.Patient 2 initial (b)(6), not repeated.A new specimen was drawn approximately 2 weeks later and was also (b)(6) using the architect method (b)(6).Other methods were (b)(6) for the second specimen.The customer stated the patients were (b)(6) three months ago, however the specific method and values were not provided.No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, labeling review, and accuracy testing.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.External commercially available seroconversion panels (zeptometrix (b)(4)) were tested with retained kits of the likely cause reagent lot.Results were compared to architect hcv test results provided by zeptometrix and the complaint lot detected the same (b)(6) with comparable (b)(6) values for the seroconversion panels.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: ARCHITECT ANTI-HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7245986
• MDR Text Key: 99818632
• Report Number: 3002809144-2018-00013
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2018
• Device Catalogue Number: 06C37-27
• Device Lot Number: 78299LI00
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER; ARCHITECT I1000SR ANALYZER; LIST NUMBER 01L86-01; LIST NUMBER 01L86-01; SERIAL NUMBER (B)(4); SERIAL NUMBER (B)(4)