Sugarbum
Well-Known Member
- Relationship to Diabetes
- Type 1
Hi guys, this came through to my inbox from a group I have joined on facebook for pumpers. Obviously I cant guarantee its source and authenticity so if you think this affects you please get in touch with the contact listed, or your clinic....🙂
Press release
Date: 06 Apr 2009
Time: 15:00
Subject: Diabetics warned about fail-ng insulin infusion pump
Contact: Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189
The Medicines and Healthcare products Regulatory Agency (MHRA) is today warning diabetic patients about problems with a portable insulin pump. Some of the Accu-Chek Spirit pumps, manufactured by Roche Diagnostics have a design fault which can cause the buttons used to adjust insulin delivery to fail.
The Accu-Chek pump has been on the market in the UK since May 2005. In the UK, 96 pumps (approximately 3.7%) have exhibited failure of one or more of the buttons.
MHRA Director of Device Technology and Safety, Clive Bray said, "The MHRA is urging diabetics who use the Accu-Chek Spirit to check the serial number of their pump, which can be found on the back of the device. Serial numbers up to and including 10006093 are affected. If you have one of these pumps, then you should contact Roche Diagnostics "
?The MHRA has issued a Medical Device Alert (MDA) today to healthcare professionals including pharmacists and specialist diabetic health workers to warn them of this problem
?We encourage people to report faulty medical devices to the MHRA using the online form on our website: www.mhra.gov.uk Reporting enquiries should be directed to the Adverse Incident Centre Hotline: 020 7084 3080, or by e-mail aic@mhra.gsi.gov.uk or fax 020 7084 3109.?
Notes to Editor
The MHRA has been informed by Roche that, due to a design fault, the operation of the pump's ?up? and ?down? arrow buttons can fail.
If both the buttons fail at the same time, the activation of the bolus function and the adjustment of the preset basal function will be inhibited.
If only one of the buttons fails, a standard bolus rate can still be programmed by using the working button to scroll through the bolus increments, as detailed in the manufacturer's instructions for use.
When the buttons fail, the basal rate infusion will continue at its existing rate.
Roche Diagnostics has not issued a field safety notice on this occasion.
Roche contact details are: Accu-Chek Pump Careline, Roche Diagnostics Ltd
Tel: 0800 731 2291 Fax: 0808 100 8060 E-mail: burgesshill.insulinpumps@roche.com
The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone ?the public and healthcare professionals as well as the industry ? to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk
Press release
Date: 06 Apr 2009
Time: 15:00
Subject: Diabetics warned about fail-ng insulin infusion pump
Contact: Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189
The Medicines and Healthcare products Regulatory Agency (MHRA) is today warning diabetic patients about problems with a portable insulin pump. Some of the Accu-Chek Spirit pumps, manufactured by Roche Diagnostics have a design fault which can cause the buttons used to adjust insulin delivery to fail.
The Accu-Chek pump has been on the market in the UK since May 2005. In the UK, 96 pumps (approximately 3.7%) have exhibited failure of one or more of the buttons.
MHRA Director of Device Technology and Safety, Clive Bray said, "The MHRA is urging diabetics who use the Accu-Chek Spirit to check the serial number of their pump, which can be found on the back of the device. Serial numbers up to and including 10006093 are affected. If you have one of these pumps, then you should contact Roche Diagnostics "
?The MHRA has issued a Medical Device Alert (MDA) today to healthcare professionals including pharmacists and specialist diabetic health workers to warn them of this problem
?We encourage people to report faulty medical devices to the MHRA using the online form on our website: www.mhra.gov.uk Reporting enquiries should be directed to the Adverse Incident Centre Hotline: 020 7084 3080, or by e-mail aic@mhra.gsi.gov.uk or fax 020 7084 3109.?
Notes to Editor
The MHRA has been informed by Roche that, due to a design fault, the operation of the pump's ?up? and ?down? arrow buttons can fail.
If both the buttons fail at the same time, the activation of the bolus function and the adjustment of the preset basal function will be inhibited.
If only one of the buttons fails, a standard bolus rate can still be programmed by using the working button to scroll through the bolus increments, as detailed in the manufacturer's instructions for use.
When the buttons fail, the basal rate infusion will continue at its existing rate.
Roche Diagnostics has not issued a field safety notice on this occasion.
Roche contact details are: Accu-Chek Pump Careline, Roche Diagnostics Ltd
Tel: 0800 731 2291 Fax: 0808 100 8060 E-mail: burgesshill.insulinpumps@roche.com
The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone ?the public and healthcare professionals as well as the industry ? to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk
