MalfunctionCGL
I-STAT CREA CARTRIDGE
Received Apr 12, 2012 · Event occurred Mar 14, 2012
Report 2245578-2012-00305 · MDR key 2557649
Device
Generic name
Crea Cartridge
Manufacturer
Abbott Point Of Care Inc.Model number
NACatalog number
03P84-25
Lot number
Y11350A
Product problems
- Incorrect Or Inadequate Test Results
Patient
88 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A DISCREPANT RESULT ON THREE PTS. THE CUSTOMER QUESTIONING I-STAT ANALYZER (B)(4) IT DOES NOT MATCH LAB AND THE OTHER I-STAT ANALYZER (B)(4). REFER TO MFR REPORT#2245578-2012-00306 (B)(4) AND 2245578-2012-00307 (B)(4) FOR OTHER PT RESULTS. BASED ON THE INFO AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.
Additional Manufacturer Narrative
(B)(4).