OtherGKP
DIAGNOSTIC STAGO
Received Sep 20, 2004 · Event occurred Apr 1, 2004
Report 2245451-2004-00002 · MDR key 5351385
Device
Generic name
Lab Instrument
Manufacturer
Diagnostica Stago, Inc.Product problems
- Incorrect Or Inadequate Test Results
- Device Operates Differently Than Expected
Patient
47 YR
- Hemorrhage, Subarachnoid
Narrative
Description of Event or Problem
EVENT DESC: PATIENT WAS IN OPERATING ROOM FOR CRANIOTOMY. BLOOD SENT FOR INR (INTERNATIONAL NORMALIZED RATIO) AND PTT (PROTHROMBIN TIME). LAB REPORTED RESULTS WHICH DEMONSTRATED PROLONGED BLEEDING TIMES AND PATIENT SURGERY WAS STOPPED AND INTERVENTIONS STARTED TO CORRECT COAGULOPATHY. ALTERNATIVE INTERVENTION PERFORMED TO ADDRESS SUBARACHNOID HEMORRHAGE. LATER FOUND THAT LAB MACHINE WAS REPORTING ERRONEOUS RESULTS. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION. THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.
Remedial action
- Inspection