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Accu-Chek® Compact test strips. Priority 2 - Warning

Notice type: Warning

Date: 17/04/2014

  

Product name or type:
Accu-Chek® Compact test strips. Priority 2 - Warning

Reference:
SN2014(18)

Manufacturer Or Supplier:
Roche Diagnostics

Target Audience:
All Hospital staff 
All Nursing Home staff 
Risk Managers 
Nursing Managers 
Hospital Pharmacists 
Diabetic Clinics/ outpatients 
Diabetic nurse specialists 
Diabetic departments 
Endocrinology units 
Endocrinology Consultants 
Paediatric wards 
Laboratory Managers 
Chief Medical Scientists 
Purchasing / Procurement / Material Managers 
Pharmacists supplying these devices 
General Practitioners 
Healthcare professionals who use these devices 
Healthcare professionals managing patients who use these devices 
Carers 
General public

Problem Or Issue:
Roche Diabetes Care has become aware of a limitation of Accu-Chek® Compact test strips and Accu-Chek® Mobile tests, which may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy (e.g. Rocephin® or Cefotrix®). This limitation is not described in the product labelling.

Background Information Or Related Documents:
Accu-Chek® Compact test strips. Priority 2 - Warning Document

Roche Diabetes Care has become aware that the use of Accu-Chek® Compact test strips and Accu-Chek® Mobile tests may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy (e.g. Rocephin®, Cefotrix®). 

The antibiotic substance ceftriaxone is used to treat a variety of infections such as respiratory infections, lower urinary tract infections, meningitis and serves as a second line therapy option for the diabetic foot syndrome and is only administered intravenously or intramuscularly. 

Patients with diabetes who are receiving this specific antibiotic therapy should stop using the blood glucose monitoring systems Accu-Chek® Compact test strips and Accu-Chek® Mobile tests and in consultation with a healthcare professional obtain an alternative blood glucose monitoring system for the duration of this therapy. For patients who are not receiving this specific antibiotic therapy Roche Diabetes Care reassures that use of Accu-Chek blood glucose monitoring systems in compliance with the labelling is safe and the results obtained are accurate and reliable.

Actions To Be Taken:
The IMB advises that users: 

(1) Determine whether you receive therapies containing the antibiotic substance ceftriaxone. 

(2) Do not use Accu-Chek® Compact test strips or Accu-Chek® Mobile tests throughout the duration of treatment with ceftriaxone. 

(3) Ensure that you can continue to monitor your blood glucose appropriately. This should be done in consultation with your healthcare professional. 

The IMB advises that healthcare professionals: 

(1) Identify all patients who receive therapies containing the antibiotic substance ceftriaxone. 

(2) Advise these patients not to use Accu-Chek® Compact test strips or Accu-Chek® Mobile tests throughout the duration of treatment with ceftriaxone. 

(3) Ensure that these patients can continue to monitor their blood glucose appropriately by providing an alternative blood glucose monitoring system. 

(4) Ensure that the appropriate personnel are made aware of this notice and the attached FSN. Please pass this Safety Notice and the attached FSN on to any end users or organisations where Accu-Chek® Compact Plus and Accu-Chek® Mobile systems may have been distributed.

Further Information:
Enquiries should be addressed to: 

Roche Diagnostics Limited 
Charles Avenue 
Burgess Hill 
West Sussex RH15 9RY 

Telephone: 1800 931 078 
Email: burgesshill.accu-chektelesalesteam@roche.com 

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

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

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie 

Please click here to view a PDF version of this safety notice

Please click here to view a copy of the field safety notice

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