Advisory on the CoaguChek® XS System, CoaguChek® XS Plus System and CoaguChek® XS Pro System

Roche Diagnostics Asia Pacific Pte Ltd, in consultation with the Health Sciences Authority (HSA), would like to inform you on the Field Safety Corrective Action (FSCA) for the CoaguChek® XS System, CoaguChek® XS Plus System and CoaguChek® XS Pro System due to an “ERROR 6” issue. The CoaguChek® XS System, CoaguChek® XS Plus System or CoaguChek® XS Pro System measures a patient's coagulation status up to an International Normalized Ratio (INR) value of 8.0. It is known that, in very rare situations, INR values greater than 8.0 can occur, for example if the patient is undergoing antibiotic treatment or chemotherapy. In patients with a very high INR value, the devices may display a message of “ERROR 6”, instead of the correct message of “INR>8” or “ERROR 7”. Please refer to the Dear Healthcare Professional Letter for more details.

 
 
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.