MalfunctionGKF
I-STAT CHEM 8+N CARTRIDGE
Received Nov 3, 2010 · Event occurred Oct 11, 2010
Report 2245578-2010-00141 · MDR key 1893966
Device
Generic name
Chem 8+ Cartridge
Manufacturer
Abbott Point Of Care Canada LtdCatalog number
03P91-25
Lot number
G10170
Product problems
- High Test Results
Patient
83 YR
- Death
- Respiratory Failure
Narrative
Additional Manufacturer Narrative
(B)(4).
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 HEMATOCRIT RESULT OF 37% PCV. A SEPARATE SAMPLE, DRAWN AT THE SAME TIME AS THE I-STAT SAMPLE, WAS TESTED ON THE LAB INSTRUMENT AND THE HEMATOCRIT RESULT WAS 15.4% PCV. NO REPEAT LABS PERFORMED. PATIENT WAS NOT TREATED ON EITHER HEMATOCRIT RESULT. PATIENT DIED OF RESPIRATORY FAILURE AT 6:30PM (B)(6) 2010.