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MDA/2006/070 - LifeScan OneTouch® Ultra®, LifeScan InDuo® and LifeScan PocketScan® blood glucose meters

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/070
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 15 December 2006 at 11:30
Ref: MDA/2006/070

 

Tick mark
Immediate action
 
Action
Tick mark
Update
 
Information request


This alert replaces the guidance issued on 04 May 2005 in MDA/2005/026, which has now been withdrawn.
Device:
LifeScan OneTouch® Ultra®, LifeScan InDuo® and LifeScan PocketScan® blood glucose meters.

>Page 2

Problem:
The units of measurement displayed may change from mmol/L to mg/dL, resulting in the user thinking that the blood glucose level is too high and thus altering the treatment regime inappropriately.

>Page 2

Action by:

  • Pharmacists supplying the OneTouch® Ultra® or PocketScan® blood glucose test strips.
  • Healthcare professionals managing patients who use these devices.
  • Healthcare professionals who use these devices.
  
Action:
Details on pages 2 and 3.

>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

>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.

>Page 4

Appendix:
Safety information sheet (in pdf only).

>Page 5



 

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 22 December 2006
Deadline (action complete): 15 March 2007


Page last modified: 07 February 2008