Paradigm insulin infusion pumps 의 안전성 경고

Safety alert

2013-03-27

2013-03-27

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130327.html

Medical device safety alert: medtronic paradigm insulin infusion pumps medical device manufacturer, medtronic inc., has initiated a medical device field safety correction action concerning paradigm insulin infusion pumps. the affected model numbers are 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. medtronic has identified three potential safety issues involving to paradigm insulin infusion pumps, as below: (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 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). as of feb 2013, 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. (2) water damage as explained in the insulin pump user guide, exposure to water can damage the pump’s internal electronics. water damage may result in insulin pump alarm or cause the buttons to stop working. although it is unlikely that water damage will occur if an insulin pump is splashed or briefly dunked, it should not be immersed in water. (3) sensor graph timeout (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.) paradigm veo insulin pump allows patient 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 2 minutes. if the sensor graph timeout is set to “none”, it can prevent the auto-resume of basal delivery 2-hours after low glucose suspend event which can result in elevate blood glucose values. this will only happen if patients go to the senor graph screen during a low glucose suspend event, and leave that screendisplayed. when this happens, the pump will beep 3 times every 15 minutes to remind patient 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. the affected users are recommended to: examine the insulin pump. if the drive support cap is sticking out, do not press on this portion of the pump. discontinue use of the insulin pump and contact medtronic to arrange replacement for the insulin pump. during this time patients will need to manage the diabetes with insulin injections, per the back-up plan provided to the healthcare professional; if to swim or participate in other water activities, always disconnect from the insulin pump, keep it in a safe place and reconnect after you are out of the water; if accidentally submerge the insulin pump in water, dry the insulin 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 it is believe that water has entered the insulin pump or is observe any other possible insulin pump malfunction, patients should contact medtronic for assistance with troubleshooting; do not change the sensor graph timeout setting to "none"; reset it if patients are using the low glucose suspend feature and have changed the sensor graph timeout setting to "none". the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 march 2013.