MalfunctionCGL
I-STAT 1 ANALYZER
Received Oct 7, 2010 · Event occurred Sep 19, 2010
Report 2245578-2010-00129 · MDR key 1868718
Device
Product problems
- Overheating of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT 1 ANALYZER WAS HOT TO TOUCH. BASED ON THE INFORMATION AT THE TIME, THERE WAS NO INJURY ASSOCIATED.
Additional Manufacturer Narrative
(B)(4).