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MDA/2007/058 - Point of care and home-use blood glucose meters: Roche Accu-Chek and Glucotrend; Abbott Diabetes Care FreeStyle

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/058
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 19 July 2007 at 15:00
Ref: MDA/2007/058
 
Immediate action
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Action
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Update
 
Information request


Device:
Point of care and home-use blood glucose meters: Roche Accu-Chek and Glucotrend; Abbott Diabetes Care FreeStyle.

>Page 2

Problem:
Risk of overestimation of blood glucose results when these meters are used on samples from patients on treatments that contain (or are metabolised to) maltose, xylose or galactose.
This problem does not apply to treatments taken orally.
This alert updates and supersedes MDA/2003/011.

>Page 2

Action by:

  • Healthcare professionals managing patients that monitor their blood glucose using these meters.
  • Healthcare professionals who use these meters.

 

Action:
Do not use affected meters to measure blood glucose in patients receiving treatments that contain (or are metabolised to) maltose, xylose or galactose.

If you are unsure if a particular patient treatment contains (or is metabolised to) maltose, xylose or galactose consult the medicines information department of your local hospital pharmacy. Telephone numbers for other medicines information services are listed in the British National Formulary (BNF).

>Page 2

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*
Social services in England - Directors*

* via CE Bulletin

>Page 3

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

>Pages 3-4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 16 August 2007
Deadline (action complete): 11 October 2007


Page last modified: 19 July 2007