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MDA/2008/009 - Blood coagulation test. SmartCheck INR system manufactured by Unipath Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/009
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Page 1

Issued: 28 February 2008 at 14:30
Ref: MDA/2008/009

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Blood coagulation test. SmartCheck INR system manufactured by Unipath Ltd.

> Page 2

Problem:
Risk of inaccurate results leading to incorrect dosing of anticoagulant therapy.

> Page 2

Action by:
General practitioners
Practice managers
Directors of pathology
Head of haematology department
Point of care test (POCT) coordinators.		  

Action:

  • Stop using the SmartCheck INR system.
  • Quarantine and return affected meters to Unipath Ltd.
  • Destroy consumables, test strips, control pack and carry cases for all affected devices.
  • Review patient results in parallel with the patient’s target therapeutic INR range and the associated anticoagulant dose.
  • Recall patients whose last dose adjustments were made using the SmartCheck INR system and retest using another method.
 

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

> Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

> Pages 2-3

Appendix:
Manufacturer field safety notice – R2008-01 (in pdf only).

> Pages 4-7



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 06 March 2008
Deadline (action complete): 28 March 2008

Page last modified: 28 February 2008