HEMOSIL VON WILLEBRAND FACTOR ACTIVITY
Received Mar 20, 2012 · Event occurred Nov 15, 2011
Report 1217183-2012-00003 · MDR key 2513240
Device
Generic name
Factor Deficiency Test
Manufacturer
Instrumentation Laboratory Co.Model number
NACatalog number
0020004700
Lot number
B11655
Product problems
- High Test Results
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
CUSTOMER INDICATED THAT THE NUMBER OF VWF ACTIVITY TO VWF ANTIGEN RATIOS HAS BEEN INCREASING. TOO MANY RATIOS ARE GREATER THAN 1.5.
Additional Manufacturer Narrative
ATTACH IS A SYNOPSIS OF THE TESTING TO DATE AND THE INVESTIGATION THAT IS ON-GOING AT THE CONTRACT MFR, BIOKIT. A FOLLOW-UP REPORT WILL BE FILED AS SOON AS THE CONCLUSION AND RISK ASSESSMENT ARE FINALIZED. CONCLUSION: A REVIEW OF THE DIFFERENCE BETWEEN COLUMNS B AND C AS WELL AS THE RATIOS IN COLUMNS D AND E INDICATES THAT THERE ARE SOME SAMPLES FOR WHICH INCUBATION WITH BOVINE IGG CAUSED THE VWF ACTIVITY RESULT AND THUS THE RATIO TO DECREASE, WHICH SUGGESTS THE PRESENCE OF HABIA IN THESE PT SAMPLES. STATUS: BIOKIT IS CURRENTLY PERFORMING FURTHER INVESTIGATION OF THE REAGENT.