FACTOR VIII ANTIBODY SCREEN
Received May 9, 2014 · Event occurred Apr 14, 2014
Report 2183608-2014-00001 · MDR key 3902584
Device
Generic name
Factor Viii Antibody Screen
Manufacturer
Immucor Gti Diagnostics, Inc.Model number
NACatalog number
F8S
Lot number
3001285
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NA
Description of Event or Problem
A CUSTOMER COMPLAINT WAS RECEIVED (CMP-216) WHICH DESCRIBED THAT THE FACTOR VIII ANTIBODY SCREEN (F8S) ASSAY RESULTS WERE NEGATIVE (NEG) AND THE LABORATORY'S IN-HOUSE (B)(6) ASSAY RESULTS WERE POSITIVE. THE ORDERING PHYSICIAN WAS EXPECTING (B)(6) RESULTS ( UNITS - BU) AND CONTACTED LAB WHEN THEY DID NOT RECEIVE THE BU RESULTS. THE LABORATORIES TESTING PARADIGM WAS TO TEST SAMPLES ON THE F8S KIT AND IF POSITIVE RESULTS (POS) WERE OBTAINED, THEN THE SAMPLE WAS REFLUXED TO THE (B)(6) ASSAY. THE INITIAL CUSTOMER NOTIFICATION WAS PROVIDED TO MANUFACTURER ON (B)(6 )2014. AFTER MULTIPLE REQUESTS OF CUSTOMER, SAMPLES WERE SENT ON (B)(6) 2014 TO MANUFACTURER. INTERNAL TESTING SHOWED THAT THE CONCERNED LOT OF PRODUCT WAS PERFORMING AS EXPECTED WHEN USING INTERNAL WELL-CHARACTERIZED SAMPLES. THE (B)(6) ASSAY IS IN INTERNAL LAB DEVELOPED TEST. THE LABORATORY HAS CHANGED THEIR TESTING PARADIGM DUE TO THIS INFORMATION TO REFLUX SAMPLES TO THE (B)(6) ASSAY IF F8S IS LESS THAN 20 PERCENT ACTIVITY.