Medtronic MMT-511 Quick Manual
Medtronic Limited
Building 9
Croxley Green Business Park
Hatters Lane
Watford
Hertfordshire
WD18 8WW
Tel:01923 212213
Fax:01923 241004
Urgent Field Safety Notice
Paradigm Pump Modes MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522,
MMT-722, MMT-722K, MMT-523, MMT-723, MMT-723K, MMT-554, and MMT-754: Recommendations
regarding use of Paradigm Pump
Paradigm Pump Models MMT-554 and MMT-754 (VEO): Recommendations for Graph settings in
Low Glucose Suspend mode
28 March 2013
Medtronic Reference: FA562
Dear Healthcare Professional,
At Medtronic, we are committed to continually evaluating and improving the quality and reliability of our
products and services. Through our monitoring system, we have learned about potential issues and we
would like to inform you about these and provide recommendations regarding the usage of our pumps.
Medtronic is directly informing patients for which we have contact details. Because Medtronic does not
have all your patients’ records on file, we kindly ask you to inform Paradigm pump users using the
enclosed letter.
1. LOOSE DRIVE SUPPORT CAP
The insulin 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.
Some customers have experienced a loose drive support cap, and in rare cases the cap may stick out
from the bottom of the reservoir compartment. This condition can occur when the insulin pump is
damaged due to impact with a hard surface (for example if it is dropped). We have one report of a
customer who attempted to push the drive support cap back into place while attached to the insulin
pump. This resulted in unintended delivery of insulin and associated severe hypoglycemia.
A normal insulin pump and an insulin pump with a loose drive support cap are shown in the pictures
below.
Normal Drive Support Cap-
Cap slightly indented
Loose Drive Support Cap-
Cap sticking out
Below are the recommendations that we are providing to patients:
•
Regularly examine your pump especially after a shock or drop on a hard surface.
•
If the drive support cap is sticking out, as shown in the photo above, do not press on this
portion of the pump and discontinue use of the pump.