OtherJJJ
ACCESS 2 IMMUNOASSAY SYSTEM
Received May 10, 2006 · Event occurred Apr 18, 2006
Report 2122870-2006-00108 · MDR key 713166
Device
Generic name
Discrete Photometric Chemistry Analyzer
Manufacturer
Beckman Coulter, Inc.Model number
ACCESS2 IMMUNOASSAY SYSTEMCatalog number
81600N
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ERRONEOUSLY ELEVATED TROPONIN (ACCU TNL) RESULT FROM A SINGLE PT SAMPLE THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. AN INITIAL WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. ON THE SAME DAY, THE PT ORIGINAL SAMPLE WAS RE-TESTED FOR ACCU TNL. THE REPEATED ACCU TNL RESULT WAS 0.03NG/ML. THE CUSTOMER DID NOT RECEIVED ANY REPORT OF PT INJURY REQUIRING MED INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT.