MalfunctionJFP
I-STAT CG8+ CARTRIDGE
Received Apr 10, 2008 · Event occurred Mar 4, 2008
Report 2245578-2008-00019 · MDR key 1028064
Device
Generic name
Ivd
Manufacturer
Abbott Point Of Care Inc.Model number
NACatalog number
03M86-01
Lot number
L07224
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IN 2008, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT AN I-STAT CG8+ CARTRIDGE YIELDED A IONIZED CALCIUM RESULT OF 1.0 MMOL/L, SAMPLE DRAWN AT 06:12. A SAMPLE, DRAWN AT 06:19, TESTED USING A LABORATORY SYSTEM YIELDED A RESULT OF 1.29 MMOL/L. CUSTOMER STATES OTHER I-STAT AND LABORATORY RESULTS CORRELATE.