OneTouch Verio IQ, Verio Pro and Verio Pro+ meters being recalled

May 24th 2013: Medtronic Paradigm ambulatory insulin infusion pumps
May 1st 2013: In the UK Medicines Device Alert was issued
April 16th 2013: FreeStyle InsuLinx blood glucose meters recalled in the US
March 25th 2013: OneTouch Verio IQ, Verio Pro and Verio Pro+ meters being recalled

Alert: Medtronic Paradigm ambulatory insulin infusion pumps

24 May 2013: the MHRA issued an alert as Medtronic have identified a risk of compromised insulin therapy when using the Paradigm ambulatory insulin infusion pumps. This may lead to severe hypoglycaemia [low blood glucose] or severe hyperglycaemia [high blood glucose].
The affected models are MMT – 511, 512, 712, 712E, 515, 715, 522, 722, 722K, 523, 723, 723K, 554 (VEO) and 754 (VEO).

The causes are:
1. Loose drive support cap (all models)
The pump is designed to withstand occasional drops or bumps, but when this happens it is recommended to check the pump for cracks or damage. The pump’s drive support cap holds the pump motor in place and allows the motor’s piston to press against the reservoir to deliver insulin.
In rare cases, if the pump is damaged due to impact with a hard surface, the cap may stick out from the bottom of the reservoir compartment. If the loose drive support cap is pressed on it could result in the unintended delivery of additional insulin.
Recommendations

• Regularly examine your pump, especially after a shock or drop on a hard surface.
• Discontinue pump use if drive support cap is loose, Do not press on this portion of the pump. Contact the manufacturer.

2. Damage to pump if immersed in water (all models)
The pump user guide, explains that exposure to water may result in pump alarm, damage of the pump’s internal electronics, or cause the buttons to stop working. For swimming or other water activities, always disconnect from your Paradigm pump, and reconnect afterwards.
If you accidentally submerge your insulin pump in water, dry the pump quickly using a soft, clean towel and verify that it is working properly by selecting Self-test from the insulin pump’s Utilities Menu. If you believe that water has entered your insulin pump or you observe any other possible insulin pump malfunction, please check your blood glucose, treat high blood glucose (if necessary) with an injection and contact your help line or representative for further assistance.
Recommendations

• Do not immerse the pump in water.

3. Programming issue related to the sensor graph timeout (Paradigm VEO MMT-554 and MMT-754 only).
This information applies only to Paradigm VEO (MMT-554 and MMT-754) pump users who are also using Medtronic Continuous Glucose Monitoring and have the Low Glucose Suspend feature enabled.
Your Paradigm VEO insulin pump allows you to set the number of minutes to display the Sensor Graph before returning to the home screen.
The factory default setting for Sensor Graph timeout is set to two minutes. If the Sensor Graph timeout is set to “NONE” it can prevent the auto-resume of basal delivery two hours after a Low Glucose Suspend event, which can result in elevated blood glucose values.
This will only happen if you go to the Sensor Graph screen during a Low Glucose Suspend event, and leave that screen displayed. When this happens, the pump will beep three times every 15 minutes to remind you that insulin delivery has been suspended. All other alarms will function normally, but basal delivery will not resume as long as the Sensor Graph screen is displayed.
Recommendations
For Paradigm VEO models:

• Do not change the Sensor Graph timeout setting to “NONE.”
• If you are using the Low Glucose Suspend feature and have changed the Sensor Graph timeout setting to “NONE,” please follow the steps below to reset it now:

1. Go to the Sensor Menu
2. Select Edit Settings, Press ACT
3. Select Graph Time Out, Press ACT
4. Select 2, 4 or 6 minutes (do not select “NONE”), Press ACT

Further information
If you are affected by this or unsure of what to do, speak to a member of your diabetes healthcare team.

Contact Medtronic
Medtronic Ltd
Lezlie Bridge
Tel: 01923 212 213
Email: lezlie.j.bridge@medtronic.com

In the UK on May 1st 2013, Medicines Device Alert was issued

May 1st 2013

If you have a Freestyle InsuLinx meter you are advised to either:

• Download new software through the Auto-Assist computer application supplied with the meter

or

• Obtain a replacement meter by contacting Abbott Diabetes Customer Service on 0800 088 5521

FreeStyle InsuLinx blood glucose meters recalled in the US

April 16th 2013

Abbott, the manufacturers of the FreeStyle Insulinx blood glucose meters have voluntarily recalled this meter in the United States because at extremely high blood glucose levels, the meter displays and stores incorrect test results much lower than the actual result.

Although extremely high results may be very rare, if they do occur, there is a serious health risk and immediate medical attention is required. As the FreeStyle InsuLinx meter can display an inaccurate low result at a blood glucose level with the very high readings, there may be a delay in the identification and treatment of severe hyperglycemia, or incorrect treatment may be given with serious consequences.

Outside the US, there have been no patient incidents reported related to this specific issue. The FreeStyle InsuLinx meter is available in Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland and United Kingdom.

Abbott has notified the US FDA and all relevant healthcare authorities in the other countries. Abbott is working with the individual regulatory agencies around the world where the affected products have been sold.

OneTouch Verio IQ, Verio Pro and Verio Pro+ meters being recalled

On March 25th 2013 Johnson & Johnson, who own Lifescan, announced that they are recalling and replacing nearly 2 million blood glucose meters due to a failure to operate properly at extremely high glucose levels. At extremely high glucose readings the meters have failed to provide a warning and will shut off potentially delaying proper treatment.

The US Food and Drug Administration and other health regulators around the world have been notified, registered users and health professionals.

The affected recalled meters are as follows:

• OneTouch Verio IQ – about 90,000 meters in the US and 1.2 million worldwide
• One Touch Verio Pro – about 670,000 in Europe
• One Touch Verio Pro+ – 4900 hospital-based meters in the Middle East, Europe and the Asia/Pacific region

The company stated that patients could continue to use the Verio IQ model until replacements arrive as long as they are aware that if the meter shuts down it could be indicative of dangerously high glucose levels.
The OneTouch Ultra model is not affected by the recall.

If you have a Lifescan OneTouch Verio blood glucose meter, please telephone LifeScan on 0800 279 9118 (UK) or 1800 535 676 (Ireland) for a replacement.