InjuryJPE
MDA ANTITHROMBIN III
Received May 27, 2004 · Event occurred Apr 23, 2004
Report 3002769706-2004-00006 · MDR key 527411
Device
Generic name
Class Ii, 864.7060 Antithrombin Iii Assay
Manufacturer
Biomerieux, Inc.Model number
*Catalog number
252574
Lot number
UNK
Product problems
- Use of Device Problem
- Low Test Results
Patient
UNKNOWN
- Treatment with medication(s)
Narrative
Description of Event or Problem
CUSTOMER CALLED TO ASK ABOUT RESULTS GIVEN WITH THE MDA ANTITHROMBIN III REAGENT (MDA ATIII). THE CUSTOMER REPORTED THAT THEY HAD QUESTIONABLY LOW RESULTS. THE CUSTOMER WAS ADVISED TO RUN WITH THE CAPS OFF RATHER THAN IN CAP PIERCING MODE. THE RESULTS WERE HIGHER AND CLOSER TO EXPECTED VALUES. THE CUSTOMER FAXED IN THE DATA WHICH SHOWED A MARKED DIFFERENCE IN RESULTS BETWEEN "CAPS ON" AND "CAPS OFF." THE CUSTOMER REPORTED THAT TWO PTS WERE PLACED ON COUMADIN BASED ON THE RESULTS WITH THE CAPS ON.
Remedial action
- Notification