MalfunctionKQG
HEMOCHRON RESPONSE COAGULATION SYSTEM
Received Apr 7, 2010
Report 2248721-2010-00069 · MDR key 1657235
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Product code (KQG)
Model (HRS.RF)
Device
Generic name
Hemochron Response Coagulation Analyzer
Manufacturer
International Technidyne Corp.Model number
HRS.RFCatalog number
HRS.RF
Product problems
- False Positive Result
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
CUSTOMER REPORTS EXPERIENCING ALLEGEDLY FALSE CELITE ACT RESULTS (>1500 SECONDS). THE FALSE RESULTS WERE RANDOM AND IN BETWEEN A RANGE OF RESULTS OF 350-600 SECONDS.
Additional Manufacturer Narrative
(B)(4). MANUFACTURER AWAITING MEDICAL DEVICE RETURN FROM CUSTOMER FOR EVAL.