Monthly Archives: January 2014

Advocate.

Warning: This is one of those posts where I’m going to dig deep inside of my head, grab a collection of thoughts, and try to make some sense of them. It’s completely unstructured, and as I start typing, I have no idea how it will end. My grade-school English teachers hate that sort of stuff.

It’s about advocacy. Or more specifically, being an advocate.

It’s a word I struggle with all the time. I can’t quite understand what it means or what obligations come with the name. Is it a role that a person chooses? Or is it a title bestowed by others based on how he or she is perceived?

Is it a privilege? A responsibility? An achievement? Maybe it’s just a self-proclamation — a sash that anyone can pick up at their local 99-cent store and sling over their shoulder. (Before you ask: I’ve never actually seen a sash that reads “Advocate” — it’s just a metaphor, and a poor one at that. But it does give me an idea…).

The term gets tossed around a lot and, to be honest, I’ve been reluctant to include myself in the group. The reason I came to the ‘net to talk about diabetes was simply that — to talk. To exchange thoughts and ideas with people like me on-line, because I really didn’t know of other Type-1’s off-line. I sought companionship and understanding, and maybe an exchange of some tricks-of-the-trade along the way.

When I sought my way into this online community, my goal was to become one friend in an established circle of friends. That was expectation, and to some extent, I’ve accomplished that. Saving the world was never on my mind.

Doing anything on a grand scale was not my ambition; I’m the type who tends to avoid the spotlight, not attract it. Never did I consider myself an Advocate.

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What’s in a name?

The “Medtronic Minimed 530G with Enlite” has got to be the longest, most convoluted name for an insulin pump. Within the first moments* of the Medtronic Diabetes Advocates Forum**, I sent out this tweet:

* “First moments” = by the time I realized that it was not inappropriate to open up a laptop and tap away on the keys while someone was speaking

** A peculiar name for the forum given that Bayer was also a host – in absentia. But a wordy name like “Medtronic Diabetes Advocates Forum presented by Bayer Diabetes Care”, although not unprecedented, would have been downright laughable.

Why did they call it that? Because “Medtronic Minimed 530G with Enlite and Bayer Contour NextLink Glucose Meter” would have been too cumbersome.

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Who, me?

I’d never been invited to anything before as a result of my participation in the DOC. So when the Direct Message came early in December, after over a month of silence on this blog,  I was a bit intrigued.

“Hi Scott – what is your preferred email address? I’d like to invite you to an event Medtronic is having,” it read, signed by one of the company’s PR folks whose name we see around the web. Naturally, a bunch of thoughts filled my head.

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Tandem issues voluntary cartridge recall

Passing along this announcement from Tandem for anyone who uses the Tandem t:slim. None of this was written by me (as you can probably tell).

– – –

FOR IMMEDIATE RELEASE

Tandem Diabetes Care Initiates Voluntary Recall for Specific Lots of Insulin Cartridges Used with t:slim Insulin Pump
Company Is Providing Replacement Cartridges to Its Customers at No Additional Charge
 
Tandem Diabetes Care Initiates Voluntary Recall for Specific Lots of Insulin Cartridges Used with t:slim Insulin Pump
Company Is Providing Replacement Cartridges to Its Customers at No Additional Charge

 SAN DIEGO, January 10, 2014 — Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim® Insulin Pump.  The affected cartridges may be at risk for leaking.  The cause of the recall was identified during Tandem’s internal product testing, and has not been associated with any complaints or adverse events reported by customers.  However, a cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

“The safety of our customers is our top priority, and we are committed to quickly addressing issues if they arise,” said Kim Blickenstaff, President and CEO of Tandem Diabetes Care. “The potential for a cartridge leak was identified during in-house product testing, and the cause has been identified.  Modifications to our cartridge manufacturing process have been implemented to prevent this issue from occurring in the future.”

Customers should discontinue using cartridges labeled with the below lot numbers, which were shipped on or after December 17, 2013.  The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).

Affected Lot Numbers

M001963
       

M001980
       

M002027
       

M002083
       

M002119

M001964
       

M001987
       

M002028
       

M002096
       

M002120

M001973
       

M001988
       

M002029
       

M002097
       

M001974
       

M001990
       

M002030
       

M002099

M001979
       

M001991
       

M002082
       

M002100
       

 

All other cartridge lots and the t:slim Insulin Pump are not affected by this recall.  Customers who received affected cartridges are being contacted by the Company or its authorized distributors and asked to call Tandem Technical Support to receive replacement cartridges at no charge.  Tandem expects to have sufficient quantities of cartridges to replace affected lots in a timely manner. Tandem Customer Support is available 24 hours a day, 7 days a week at 1-877-801-6901.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with insulin-dependent diabetes. The Company manufactures and sells the t:slim Insulin Pump, the slimmest and smallest durable insulin pump currently on the market, and the first and only with a high resolution, color touch screen. Tandem is based in San Diego, Calif.

Forward Looking Statement

This press release includes forward-looking statements concerning Tandem’s voluntary recall of specific lots of cartridges that are used with the t:slim® Insulin Pump, the scope of the recall, the cause of the potential cartridge leak, the implementation of remedial actions that are intended to prevent this issue from occurring in the future, and Tandem’s ability to replace affected cartridges on a timely basis. Tandem’s actual results may differ materially from those indicated in these forward looking statements due to risks and uncertainties, including: future actions of the FDA or any other regulatory body or governmental authority; Tandem’s ability to modify its cartridge manufacturing process in order to prevent this issue from occurring in the future; Tandem’s reliance on distributors to facilitate the product recall; the potential that Tandem may subsequently discover additional lots of cartridges subject to this recall; the possibility that this recall could subject Tandem to claims or proceedings which may adversely impact its business and financial condition; and other risks identified in Tandem’s Registration Statement on Form S-1. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update any forward-looking statement in this press release.

WWednesday: The broken ones

image

What do you do with the broken ones? I generally transfer my glucose tabs to the smaller tube, but it’s hardly worth the dusty mess.