MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. FACTOR VIII ANTIBODY SCREEN

Catalog Number	F8S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complaint (b)(4) was received on (b)(6) 2017 for factor viii antibody screen (303283) lot 3004682.The customer reported that a (b)(6) year old male patient had factor viii antibody screen assay results that were negative, and the laboratory's bethesda assay results were positive (2.4 titer).Factor vii antibody screen assay results are also dependent on the progression of antibody formation as well as if/when fviii therapy is administered.The patient's course of therapy was not available from the laboratory.

• Brand Name: FACTOR VIII ANTIBODY SCREEN
• Common Device Name: FACTOR VIII ANTIBODY SCREEN
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7706639
• Report Number: 2183608-2018-00002
• Device Sequence Number: 16541219
• Product Code: GGP
• UDI-Device Identifier: 10888234500001
• UDI-Public: 10888234500001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: No Information
• Device Expiration Date: 09/15/2018
• Device Catalogue Number: F8S
• Device Lot Number: 3004682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR