Yes… that is the title of a letter I received from Medtronic Australia a few days ago. No wonder I instinctively reached for my pump and disconnected, even before reading the content of this “urgent” letter.
As it turns out, the supposedly important alert does not seem to be anything other than a simple clarifycation, probably made “urgent” by the need of Medtronic to cover any liability risk. Further to this, the letter is only related to the Continuous Glucose Monitoring capabilities of the Paradigm pump, so the amount of people potentially impacted is very small. Nevertheless all Paradigm users in Australia seem to have received the letter.
In October last year, Medtronic increased the lifespan of it’s sensors to 6 days instead of 3. While new pumps are programed for this change, everyone who got a pump a while ago is still faced with and “End of Sensor” message after 3 days.
The purpose of this latest message from Medtronic is to advise that “you should be aware of the following:
1.- The first sensor alert after 3 days of sensor use may be treated as an advisory reminding you that the sensor will need to be changed in a further 3 days”.
Is this a joke or what?
Ah!, and of course there is a subtle word or warning before the letter concludes:
“The sensor must not be used for more than 6 days as the accuracy of the sensor cannot be guaranteed”
Hmm… let me think… isn’t that the case for the whole life of the sensor.
I think Medtronic should pay more attention to communications with its consumers if they are to live to the expectations of being leaders in that market.
Posted by Henry 
According to the study “The Medtronic MiniMed Subcutaneous Glucose Sensor was originally approved by the FDA for commercialization as part of the Continuous Glucose Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The Sensor is composed of a microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible membrane. This same sensor is used as part of the Guardian REAL-Time System, the latest advance in continuous glucose monitoring, which is based on the CGMS. Similar to the CGMS, the Guardian REAL-Time System has been developed for use in conjunction with a standard home blood glucose meter. The Guardian REAL-Time received regulatory approval from the FDA in 2006. As currently used, the Subcutaneous Glucose Sensor is labeled for a maximum use duration of 72 hours, using only the abdomen area as an insertion site. Recent studies have shown that the useful sensor life could extend beyond three days, and it is reasonable to expect a significant percentage of sensors to last six days. It is the goal of this study to confirm sensor performance accuracy data from one of these recent studies. The sensor is also commonly worn in body areas other than the abdomen (such as the buttock). This study will also demonstrate sensor accuracy when used in an alternate site.”
This week I had the opportunity to attend the Insulin Pump Expo 2009. This event is organized by The local chapter of Diabetes Australia, and brings together the diabetes community interested in Insulin Pumps. There were two presentaton tracks on the day, one for prospective pumpers and an advanced one for those of us who have been pumping for a while.
