MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ANTI-HCV

Catalog Number	01L79-35
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, device history review, and sensitivity testing.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Device history review did not identify any issues that may have caused the customer issue.The product was not returned.An internal panel was tested with retained kits of the likely cause reagent lot and sensitivity testing met all specifications.Sensitivity was also evaluated by testing two commercially available seroconversion panels, zeptometrix hcv 9041 and hcv 9045.The complaint lot detected the same bleeds as (b)(6) with comparable s/co values as historical architect anti-hcv test results provided by zeptometrix.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.
Event or Problem Description
The customer observed (b)(6) results while using the architect anti-hcv reagents.The following information was provided.(b)(6).No impact to patient management was reported.

• Brand Name: ARCHITECT ANTI-HCV
• Common Device Name: ANTI-HCV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 6595746
• Report Number: 3002809144-2017-00080
• Device Sequence Number: 13662608
• Product Code: MZO
• UDI-Device Identifier: 00380740001421
• UDI-Public: (01)00380740001421(17)170627(10)67316LI00
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2017

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: 06/27/2017
• Device Catalogue Number: 01L79-35
• Device Lot Number: 67316LI00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1