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MDA/2006/035 - FreeStyle™, FreeStyle Mini™ and MediSense Optium Xceed™ blood glucose meters manufactured by Abbott Diabetes Care

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/035
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 08 June 2006 at 11:00
Ref: MDA/2006/035

 

Tick mark
Immediate action
 
Action
Tick mark
Update
 
Information request


This alert replaces the guidance issued on 13 March 2006 in MDA/2006/018, which has now been withdrawn.
Device:
FreeStyle™, FreeStyle Mini™ and MediSense Optium Xceed™ blood glucose meters manufactured by Abbott Diabetes Care.

 

Problem:
The units of measurement displayed on the blood glucose meter may change from mmol/L to mg/dL, resulting in the meter user thinking that the blood glucose level is too high.

The MHRA is aware of two different causes of this problem and the action has been extended.

>Page 2

Action by:

  • Pharmacists supplying these devices or the FreeStyle test strips or Optium Plus test strips.
  • Healthcare professionals managing patients who use these devices.
  • Healthcare professionals who use these devices.

 
Action:
Users may need to obtain a replacement meter from the manufacturer.

>Pages 2-3

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

  

>Pages 3-4
Contacts:
Details of manufacturer/supplier contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address lsit for CSCI and Healthcare Commission.

>Pages 4-5
Appendix:
Safety information sheet.

>Page 6


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 15 June 2006
Deadline (action complete): 15 December 2006
Note to SABS Liaison Officers:
In order to close electronic response form for MDA/2006/018, select "No action is required", indicating "Alert superseded by MDA/2006/035" in the action text box.


Page last modified: 08 June 2006