OtherJHE
ABBOTT AXSYM SYSTEM
Received Feb 21, 2005 · Event occurred Jan 13, 2005
Report 1628664-2005-00005 · MDR key 578096
Device
Generic name
Automated Immunaossay Analyzer
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
7A83-01
Lot number
NA
Product problems
- False Negative Result
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED AXSYM IMPRECISION WHILE TESTING PT SAMPLES. A SAMPLE TEST TESTED AXSYM TOXOPLASMA IGM NEGATIVE (0.36 INDEX VALUE) IN 2005 RETESTED TOXOPLASMA IGM POSTIVE AT ANOTHER FACILITY USING BECKMAN ACCESS METHOD. THE SAME PT WAS REDRAWN IN 02/2005 AND THE AXSYM TOXOPLASMA IGM RESULT WAS POSITIVE (2.75 INDEX VALUE). NO IMPACT TO PT MANAGEMDENT WAS REPORTED.