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I-STAT CHEM 8+ CARTRIDGE

Received Jul 10, 2009 · Event occurred Jun 12, 2009

Report 2245578-2009-00018 · MDR key 1421676

Device

Generic name

Chem 8+ Cartridge

Catalog number

03M88-01

Lot number

P09063A

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

53 YR

  • No Code Available

Narrative

Description of Event or Problem

ON (B)(6) 2009, ABBOTT POINT OF ACRE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT AN I-STAT CHEM 8+ CARTRIDGE YIELDED A HEMATOCRIT RESULT OF 28% PCV. THE SAMPLE (UNK IF THE SAME SAMPLE) USING A LABORATORY SYSTEM YIELDED A HEMATOCRIT RESULT OF 23% PCV. THERE WAS A DELAY (TIME FRAME UNK) ON THE TRANSFUSION TO THE PATIENT. THERE IS NOT INDICATION OF THE I-STAT CHEM 8+ CARTRIDGE MALFUNCTIONING. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.