OtherGKF
I-STAT EG7+ CARTRIDGE
Received Mar 5, 2009 · Event occurred Feb 16, 2009
Report 2245578-2009-00005 · MDR key 1345040
Device
Generic name
Eg7+ Cartridge
Manufacturer
Abbott Point Of Care Canada Ltd.Model number
NACatalog number
06F01-01
Lot number
P08326A
Product problems
- Incorrect Or Inadequate Test Results
Patient
63 YR
- No Code Available
Narrative
Description of Event or Problem
ON (B) (6) 2009, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED AN I-STAT EG7+ CARTRIDGE FIELDED A HEMATOCRIT RESULT OF 19%. THE SAME SAMPLE TESTED USING A LABORATORY SYSTEM YIELDED A HEMATOCRIT RESULT OF 23%. THE PT WAS GIVEN A TRANSFUSION (PACKED RED BLOOD CELLS) BASED ON THE I-STAT RESULT.