MalfunctionGGP
FACTOR VIII ANTIBODY SCREEN
Received Jul 20, 2018 · Event occurred Nov 27, 2017
Report 2183608-2018-00002 · MDR key 7706639
Device
Generic name
Factor Viii Antibody Screen
Manufacturer
Immucor Gti Diagnostics, Inc.Catalog number
F8S
Lot number
3004682
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
70 YR
- No Known Impact Or Consequence To Patient
- Missing Value Reason
- No Known Impact Or Consequence To Patient
- Missing Value Reason
Narrative
Description of Event or Problem
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.