MalfunctionJHW
AXSYM CK-MB
Received Feb 24, 2010 · Event occurred Feb 11, 2010
Report 1628664-2010-00095 · MDR key 1613620
Device
Generic name
For The Quantitative Determination Of The Mb Isoenzyme Of Creatine Kinase
Manufacturer
Abbott LaboratoriesCatalog number
7A57-20
Lot number
83465Q100
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER STATES THAT A SAMPLE FROM ONE PATIENT PROCESSED USING THE AXSYM CK MB ASSAY GENERATED A FALSELY DECREASED RESULT. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED RELATED TO THIS ISSUE.