InjuryCGL
I-STAT CHEM 8+N CARTRIDGE
Received Aug 27, 2010 · Event occurred Jan 1, 2010
Report 2245578-2010-00116 · MDR key 1820716
Device
Generic name
Chem 8+ Cartridge
Manufacturer
Abbott Point Of Care Canada Ltd.Catalog number
03M88-01
Lot number
G10150A
Product problems
- Low Test Results
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT CHEM 8+ CARTRIDGE YIELDED A CREATINE RESULT OF 1.3 MG/DL. SAME SAMPLE, TESTED USING A LABORATORY INSTRUMENT YIELDED A RESULT OF 2.1 MG/DL, REPEATED 2.0 MG/DL. AS A RESULT OF THE I-STAT CREATINE RESULT OF 1.3 MG/DL, THE PHYSICIAN GAVE CONTRAST FOR THE CT SCAN. PT WAS ADMITTED TO THE HOSPITAL.
Additional Manufacturer Narrative
(B)(4).