MalfunctionKQG
HEMOCHRON RESPONSE COAGULATION SYSTEM
Received May 19, 2010 · Event occurred Feb 23, 2010
Report 2248721-2010-00083 · MDR key 1701345
Device
Generic name
Hemochron Response Coagulation Analyzer
Manufacturer
International Technidyne Corp.Model number
HRS.110Catalog number
HRS.110
Product problems
- High Test Results
Patient
66 YR
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). MFR AWAITING PRODUCT RETURN FOR EVAL.
Description of Event or Problem
HEALTH CARE PROFESSIONAL: REPORTS HEMOCHRON RESPONSE PROBLEM. CUSTOMER CLAIMS HEMOCHRON RESPONSE GIVING ERRONEOUS RESULTS. WELL 1 GIVES HIGH RESULTS AND WHEN SOME SAMPLE IS REPEATED ON ANOTHER INSTRUMENT, EXPECTED RESULT IS DERIVED.