InjuryJJC
AIA-600 II
Received Jul 12, 2005 · Event occurred Jun 13, 2005
Report 2950409-2005-00030 · MDR key 743782
Device
Generic name
Enzyme Immunoassay Analyzer
Manufacturer
Tosoh CorpModel number
AIA-600 IICatalog number
019328
Lot number
*
Product problems
- High Test Results
Patient
*
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
CUSTOMER REPORTED ELEVATED RESULTS ON A PT FOR CKMB, MYOGLOBIN AND TROPONIN I. ALL RESULTS HAD A "DL" FLAG. PT TRANSPORTED TO ANOTHER FACILITY AS A RESULT DUE TO ELEVATED RESULTS. RESULTS WERE QUESTIONED AT OTHER FACILITY AND TESTS WERE RE-RUN. CUSTOMER INFORMED THAT RESULTS WITH A "DL" FLAG WERE NOT TO BE REPORTED.