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Blood Glucose Meters and Test Strips 23.10.2009

Notice type: Warning

Date: 23/10/2009

  

Product name or type:
Optium Xceed meters manufactured by Abbott Diabetes Care; Boots brand meters; OneTouch Ultra test strips manufactured by LifeScan

Reference:
IMB Safety Notice: SN2009(08)

Manufacturer Or Supplier:
Abbott Diabetes Care 
LifeScan 
Boots 

Target Audience:
• Pharmacists supplying these devices. 
• GPs who prescribe test strips. 
• Healthcare professionals, including diabetes specialist nurses, managing patients who use these devices. 
• Healthcare professionals who use these devices. 
• General public. 

Problem Or Issue:
The Optium Xceed blood glucose meter (manufactured by Abbott Diabetes Care) or Boots brand blood glucose meters, may generate incorrect results when used in conjunction with the OneTouch Ultra test strips, manufactured by LifeScan.

Background Information Or Related Documents:
In February 2008 the Medicines and Healthcare products Regulatory Agency (MHRA) circulated a Medical Devices Alert (MDA) advising of cases where incorrect results were obtained from Optium Xceed meters when used in combination with One Touch Ultra test strips. The Irish Medicines Board (IMB) circulated this MDA alert (MDA/2008/006) to all Irish hospitals in February 2008. 

Since February 2008 the IMB has been informed of two further incidents in Ireland where incorrect results were obtained from Optium Xceed meters used in conjunction with OneTouch Ultra test strips. In one incident a patient adjusted their insulin treatment based on the readings generated by the Optium Xceed meter with the OneTouch Ultra test strips. The patient was admitted to hospital and diagnosed with Diabetic Ketoacidosis (DKA). 

The IMB wish to reiterate that OneTouch Ultra test strips are not intended for use with Optium Xceed or Boots brand meters. The labelling (outer carton and instructions for use) for OneTouch Ultra test strips states that OneTouch Ultra test strips should only be used with OneTouch brand meters. The User Guide for the Optium Xceed meter also restricts users to use only Abbott Diabetes Care Optium Plus test strips. In some instances an error code is not generated when OneTouch Ultra test strips are used in combination with the Optium Xceed or Boots brand meters and a lower than expected blood glucose reading may be obtained. However, on insertion of the incorrect strip, the meter will display the incorrect calibration “Lot” number. 

Blood Glucose Meters and Test Strips 23.10.2009 Document

Actions To Be Taken:

The IMB recommends that users follow the manufacturer’s instructions for use and User’s Guide to determine which blood glucose meters and test strips are compatible. 

Table showing compatible meters and test strips 

Manufacturer

Meter

Compatible test strip

Abbott Diabetes Care

Optium Xceed

Optium Plus test strips
(foil wrapped)

Boots

Boots Brand

Optium Plus test strips
(foil wrapped)

LifeScan

OneTouch Ultra
OneTouch Ultra 2
OneTouch UltraEasy
OneTouch UltraSmart

OneTouch Ultra test strips

Pharmacists supplying OneTouch Ultra test strips and Optium Xceed or Boots brand meters: 

  • If you supply Optium Xceed or Boots brand meters you should advise the user to only use Optium Plus test strips.
  • When you dispense OneTouch Ultra test strips you should advise the user that these test strips are only intended for use with the OneTouch Ultra brand meters.

 

GPs prescribing blood glucose meter test strips:

  • Only prescribe Optium Plus test strips for use with Optium Xceed or Boots brand meters. 
  • Only prescribe OneTouch Ultra test strips for use with OneTouch Ultra brand meters. 

Healthcare professionals managing patients who use the affected devices:  

  • Advise patients to ensure that they are using the correct test strips for their meter as described in the meter’s user manual.  

     

Healthcare professionals who use these devices: 

  • Ensure that Optium Plus test strips are only used with the Optium Xceed or Boots brand meters.
  • Ensure that OneTouch Ultra test strips are only used with the OneTouch Ultra brand meters.

General public: 

  • Only use Optium Plus test strips with the Optium Xceed or Boots brand meters.
  • Only use OneTouch Ultra test strips with OneTouch Ultra brand meters.

Please bring this safety notice to the attention of all who need to be aware of it. This will include further distribution to: 

Accident & Emergency Departments 
All wards 
Ambulance services directors 
Ambulance staff 
Biochemists 
Chief pharmacists 
Clinical pathologists 
Clinical pathology directors 
Day surgery units 
Diabetes clinics / outpatients 
Diabetes nurse specialists 
Hospital pharmacists 
Medical Directors 
Nursing executive directors 
Outpatient clinics 
Outpatient theatre managers 
Outpatients theatre nurses 
Pharmacists 
Point of care testing co-ordinators 
Risk managers 

The IMB has also published an Information leaflet on safety tips for blood glucose meters. Please see the Information leaflets section on the Publications page of the website. 

Further Information:
All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 

Enquiries to the manufacturer should be addressed to: 

Abbott Diabetes Care 
4051 Kingswood Drive 
Citywest Business 
Tallaght Dublin 24 
Ireland 

Telephone: +1-4691570 (press 2)
Fax: +1 4691565


LifeScan Customer Care 
50-100 Holmers Farm Way 
Campus High Wycombe 
Buckinghamshire HP12 4DP 
UK 

Tel: 1800 535676 (Ireland) 
0800 121200 (UK) 

Download: SN200908_Blood Glucose Meters And Test Strips

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