inforMED
MalfunctionGIO

COAGUCHEK PRO CAPILLARY BLOOD COLLECTION SYSTEM

Received Jan 30, 2007 · Event occurred Jan 1, 2007

Report 1823260-2007-01007 · MDR key 823648

Device

Generic name

Capillary Tube - Gio

Manufacturer

Roche Diagnostics

Model number

*

Catalog number

11621173001

Lot number

*

Product problems

  • Use of Device Problem
  • Other (for use when an appropriate device code cannot be identified)

Patient

NA

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

CALLER STATES THAT SHE WAS USING THE CAPILLARY TUBE AND BLOOD SPLATTERED ON HER FACE TWICE. CALLER STATES THIS HAS HAPPENED TO ANOTHER EMPLOYEE AS WELL. NO ADVERSE EVENT REPORTED. CUSTOMER WAS PUTTING THE BULB ON AFTER BLOOD WAS DRAWN, AGAINST LABELING.