inforMED
OtherGKP

DIAGNOSTIC STAGO

Received Sep 20, 2004 · Event occurred Apr 1, 2004

Report 2245451-2004-00002 · MDR key 5351385

Device

Generic name

Lab Instrument

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