InjuryJJC
AIA-600 II
Received Jul 20, 2005 · Event occurred Jun 20, 2005
Report 2950409-2005-00031 · MDR key 747215
Device
Generic name
Enzyme Immunoassay Analyzer
Manufacturer
Tosoh Corp.Model number
AIA-600 IICatalog number
019328
Lot number
*
Product problems
- Failure, intermittent
- False Positive Result
- High Test Results
Patient
*
- Therapy/non-surgical treatment, unncessary
- Hospitalization required
Narrative
Description of Event or Problem
EVENING OF 6/20/05: PT RESULT FOR CTNI REPORTED OUT AS 5.61; REPEAT RESULT WAS <L (<0.06). REFERENCE RANGE IS 0.31-0.64 NG/ML. TREATMENT FOR PT WAS STARTED BASED ON ORIGINAL RESULT. PT HAD HAD A HEART ATTACK PREVIOUSLY AND WAS ALREADY ON "BLOOD THINNERS". REPORTER STATED THAT THE PHYSICIAN SAID THE TREATMENT WAS NOT "AGGRESSIVE".