November 8, 2010

Dear Vendor

Your living depends on quality delivery of diabetes products. Our kids lives depend on them. It almost sounds the same but lest there be any confusion the difference is a quantum leap. Y'all would do well to project an understanding of that.

I was in the lobby of one of our vendors a few weeks ago and read a poster on the wall extorting the employees to achieve the 2009 goals. It being the tenth month of 2010, I wonder if they made the 2009 goals, or if the staff even sees the sign as they walk past since the poster, having been up for deep into the next year, had become invisible. In part the sign read, "deliver the highest quality diabetes products and services to our customers while ensuring compliance and profitable growth." It also talked about putting the "customer at the center." of quality and delivery.

Wouldn't it be great to be at the center of quality delivery? I would be a huge cheer leader for your profits if I felt my kids were at the center of your business behaviors.

I would think that would putting the customer at the center would include responding to or even acknowledging customer contact in a way that is useful and in kind with how customer the contact the company.

A month ago I wrote this particular vendor a letter. Neither of the executives who were recipients have made any reply. A third party support person called my cell about a week later with instructions on how to use my computer to manage the meter and pump in a work around. I was at my daughter's field hockey game. I did not have access to a computer or the meter. Getting the pump would require actually stopping the game. So I asked for an email. I like written instructions - I know it is old school, but I'm old. I was assured I would have that email the next day. It was a little late to get it out that afternoon and I didn't expect the caller to get home to his family dinner late so I figured one day was fine.

Never got'm.

I called a week or more later and after some fairly aggressive insistence about escalating on the line rather than waiting for another call back or email, I was told I that write instructions would require approval. Really? I can expect a call back in two business days that will update the status of getting a written reply. (There is a weekend in there so it four days with diabetes because diabetes doesn't take weekends off, I think weekend off would be a big improvement in diabetes care by the way.) I got that call and they said they were still 'working on it.'

I spoke to one of the recipients of my letter today. I was assured they had seen the written reply to my letter and the instruction for a work around. That nice. I haven't.

At the center of it all is we still have manage diabetes. Unlike a vendor the kids don't get to wait a month to think over how to respond to it.

So One Touch, that 2009 goal about customer at the center of quality delivery - care to grade yourself on this issue?

October 6, 2010

One Touch Ping - Compliance
200 Lawrence Drive
West Chester PA 19380

Ms X and Mr Y,
I am the parent two teenage minor children who use One Touch Ping pumps. The Ping meter remote and the insulin pump are designed to work together as a system by patients. In our cases by pediatric patients. With two Ping users in the house we have two OneTouch Ping Meter Remotes. The meters remotes are the same color, design and do not appear from the documentation to support user identification by name the remote screens via software customization. Short of the serial numbers these remotes are indistinguishable.

In a multi pump household, the indistinguishable remotes and lack of in device personalization presents a strong possibility of confusion and the very real possibility of one child entering an insulin dose that is delivered to the other’s pump. This would require that both the confused pumps and remotes be in common transmission and reception range. That happens at regular times, such as at a family meal. In fact insulin pumps are designed for use in conjunction with meals. The use of pumps (is common) at every family meal in type 1 households.
Lables, stickers and skins can be used to identify remotes but can all wear off or be removed. Customization of the home screen of the remote / meter with the user name would allow clear positive identification of who’s pump each identical remote controls.

OneTouch suggest that users check the serial number of the pump that can be displayed on the meter. Those numbers are long, not intuitive and potentially difficult for a pediatric patient to remember. The process of calculating and administering an insulin bolus involves an array of number; blood glucose, carb count, insulin to carb ratio and insulin on board to name a few. These numbers have the potential confusing the recall of the serial number.

Hyperglycemia may exacerbate the risk. Linda Gonder-Frederick, PhD et al demonstrates in the article Cognitive Function Is Disrupted by Both Hypo- and Hyperglycemia in School-AgedChildren With Type 1 Diabetes: A Field Study, Diabetes Care, June 2009, that hyperglycemia effects the cognitive function of school age children. Hyperglycemia require more insulin than would otherwise be infused as a correction bolus. However at the time more insulin is needed ability may be impaired and the potential confusing the recall of the serial number increases.

Were this confusion of remotes used to operate pumps to happen there is a very real possibility of excessive insulin delivery. Animas is aware of the risks of excessive insulin delivery. The phrase that is used repeatedly in the Ping Owner’s booklet, bolded and highlighted, is “... can result in serious injury or death.”

Section II, of the Owner’s booklet titled OneTouchPing Meter Remote, pages 107 - 126 details setting up the OneTouch Ping Meter Remote. Page 109 specifically speaks to the device home screen. Pages 114-118 address customization. In repeated readings I was unable to identify any customization of the OneTouch Ping Meter Remote that would facilitate naming or other easily understood personal identification of the user on the home screen or via customization settings.

Use of remotes for different pumping patients in the same household represents a potential serious risk as designed.

Sincerely yours,

cc: FDA

My post with a reply is here:

Editors note: I removed the names of the contacts at One Touch. It seemed more fair to focus on the organizational behavior and less on individuals. - YDMV