OtherJPA
COMPACT
Received Sep 10, 2004 · Event occurred Sep 1, 2004
Report 549982 · MDR key 549982
Device
Generic name
Coagulation Analyzer
Manufacturer
Diagnostica Stago, Inc.Model number
*Catalog number
*
Lot number
*
Product problems
- High Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
SAMPLE WAS PUT ON COAGULATION INSTRUMENT TO TEST A PTT, PARTIAL THROMBOPLASTIN TIME. FIRST RESULT WAS GREATER THAN 300 SECONDS. INSTRUMENT AUTOMATICALLY REPEATED THE TEST AND RESULTED AS GREATER THAN 300 SECONDS FOR THE SECOND TIME. SAMPLE WAS CHECKED FOR CLOT AND RESULT TURNED OUT NO CLOT WAS FOUND. SAMPLE WAS CENTRIFUGED AND REPEATED. AGAIN, FIRST RESULT WAS GREATER THAN 300 THEN INSTRUMENT AUTO-REPEATED WITH A RESULT OF 79.8 SECONDS.