InjuryJJC
AIA-600 II
Received Sep 13, 2005 · Event occurred Aug 25, 2005
Report 2950409-2005-00032 · MDR key 643733
Device
Generic name
Enzyme Immunoassay Analyzer
Manufacturer
Tosoh Corp.Model number
AIA-600 IICatalog number
019328
Lot number
*
Product problems
- Incorrect Or Inadequate Test Results
Patient
*
- Hospitalization required
Narrative
Description of Event or Problem
A POSITIVE TROPONIN RESULT WAS REPORTED TO A PHYSICIAN, THAT A PT WAS ADMITTED, RETESTED AND REPEAT RESULTS WERE NEGATIVE. DATES ABOUT ORIGINAL TEST RESULT WERE NOT AVAILABLE, RETEST RESULTS/METHOD ALSO NOT AVAILABLE. SAYS PROBLEM IS NOT SEEN ON TROPONIN CONTROLS, ONLY PATIENTS.