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New PDM

Discussion in 'Parents of Children with Type 1' started by lil'Man'sMom, Dec 12, 2011.

  1. lil'Man'sMom

    lil'Man'sMom Approved members

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    We had to get a new PDM, ours had a big "ink spot" on the screen. I called Insulet late Thursday afternoon, the new one arrived Friday. Made us happy because the syringe thing was already wearing thin.

    Manning came home today saying that the new PDM is different (I had used it all weekend and didn't notice). 'Freestyle' is printed on the bottom of the screen of the PDM.

    I called Insulet, as I was curious if the Freestyle test strips had been approved and I just missed it. Nope, well in Canada but not the US. I asked why they had the Freestyle logo on the PDM. No clue.... but they still can not recommend using the strips with the PDM (in the US). :rolleyes:
     
    Last edited: Dec 12, 2011
  2. swellman

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    That's interesting ... I'm guessing there's a new hardware or firmware. What is the model and revision on the back?
     
  3. lil'Man'sMom

    lil'Man'sMom Approved members

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    13050-AW Rev C

    So if there is new hardware/firmware do they not need FDA approval for the revision or only if they deviate?
     
  4. swellman

    swellman Approved members

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    I think that's our hard revision as well. Maybe there's a software revision.

    I can't say for sure but it wouldn't surprise me if changes that are minor only need notification. I am assuming here because I don't have any exposure to devices - only drugs. For instance, I can't imagine a change that resulted in merely a graphic change would need approval but, again, I really don't know.

    I do know that I tried to find a firmware version on the thing and couldn't find it anywhere. I would have sworn in was in there somewhere.
     
  5. Rick

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    The firmware version is displayed in the header of the "Omnipod PDM Settings Report".
     
  6. swellman

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    In CoPilot, ah ... I knew I saw it somewhere.
     

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