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MDA/2007/059 - Point of care blood glucose measurement systems: HemoCue Glucose 201+ and HemoCue Glucose 201 RT

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/059
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: 2 August 2007 at 10:00
Ref: MDA/2007/059


 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Point of care blood glucose measurement systems:
HemoCue Glucose 201+ and HemoCue Glucose 201 RT.		  
Problem:
Potential for false zero readings of blood glucose concentration.

>Page 2

Action by:
All staff treating patients based on results from these devices.
Healthcare personnel procuring, using or managing these devices.		  

Action:

  • If you obtain a zero reading with this analyser turn it off, switch it back on again and repeat the measurement.
  • Contact the manufacturer for a software upgrade for devices purchased/supplied before January 2007.
  

Distributed to:

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

* 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 re-issued on 25/06/07.

>Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 09 August 2007
Deadline (action complete): 06 September 2007


Page last modified: 02 August 2007