Medtronic Safety Alert

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.

Share

Advertisements

3 Responses to Medtronic Safety Alert

  1. kb1mdtanz says:

    Hi Henry,

    The term “Safety Alert” was a requirement of the Therapeutic Goods Administration. We’re sorry it caused you undue concern.

    Kerryn Burke
    Medtronic Australasia

    • Henry says:

      Hi Kerryn,

      I understand that sometimes government agencies put specific (and sometimes hard to understand) requirements to drug and medical services companies. Unfortunately in this case TGA’s requirement seem to have caused more confusion than ideal.

      Thanks for the clarifying the issue.

      Henry.-

  2. Harbor says:

    I understand that sometimes government agencies put specific (and sometimes hard to understand) requirements to drug and medical services companies. Unfortunately in this case TGA’s requirement seem to have caused more confusion than ideal.
    +1

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: