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MDA/2009/019 - Insulin pen injection devices: Owen Mumford Autopen Classic (1 unit 3ml), 1-21 units

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Document details:

Type: Medical Device Alert
Series No: MDA/2009/019
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 9
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 16 March 2009 at 15:30
Ref: MDA/2009/019

 

Tick mark
Immediate action
 
Immediate action update
 
Action
 
Action update


Device:
Insulin pen injection devices: Owen Mumford Autopen® Classic (1 unit 3ml), 1-21 units. Product code: AN3810 Affected lots: CJF, DBR, DEX, DMP, DND BRG and CCW.

Owen Mumford Autopen Classic

 
Problem:
Affected devices may fail to dispense insulin. Underdosing of insulin may lead to hyperglycaemia, which could lead to long term deterioration in health.
  • Action:
    Advise users of affected product to seek a replacement pen, and to prime the device prior to each injection.
  • Discontinue supply of all affected product.
  • Quarantine and return the remaining stock to the manufacturer.

Action by:

  • Pharmacists
  • Healthcare professionals
  • Those involved in purchasing, supplying and using these devices.

Contact:

Mrs Doreen Trezise
Customer Services Manager
Owen Mumford Ltd

Tel: 01993 812021
Fax: 01993 813466

E-mail: doreen.trezise@owenmumford.co.uk



Action deadlines for the Central Alerting System (CAS)
Deadline (action underway): 30 March 2009
Deadline (action complete): 20 April 2009


Page last modified: 16 March 2009