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Archive for the 'Product Safety' Category

The Mystery Bolus

Monday, November 12th, 2007

Insulin pump therapy in children and teenagers never ceases to surprise me. Just when you think you’ve seen it all, along comes a new twist. The latest seems to be the “mystery bolus” and its first cousin, the “sleep bolus”.

Only Pumpers Would Appreciate This:

I’ve been seeing more and more kids and teens who have unexplained bolus doses of insulin when the devices are downloaded in the office. Often these occur during the middle of the night. While some may be recalled many are not.

Today I saw a young lady who had two episodes of severe hypoglycemia resulting in the parents stopping her pump until she came in for a check up. When the pump memory was examined, there were large boluses given within 30-45 minutes of the two events. The parents of this teen never check the bolus history, but were surprised (as was the girl, who has no evidence of secondary gain from this behavior) by these boluses.

Over the past year, I’ve seen other children do similar things.

One boy bolted up in his bed at 4:30 AM, dreaming that his mother had called him down for breakfast, then proceeded to bolus himself and fall back to sleep, only to be found severely hypoglycemic at 6:30 when the parents came to awake him. Beyond the sleep bolus, the “mystery” bolus is far more common.

At our children’s diabetes camp, the staff is obliged to check the bolus histories on all campers each day to verify dosing. It is now commonplace to find boluses that the child can’t (or won’t) explain. Many of these cases are teen boys who most likely are bolusing for contraband food, snacks or even sugar cubes. The pump enables this behavior in quite a perfect way.

There is often little parental review of the bolus history by many parents. The child has a ready supply of insulin to take for whatever extra food they wish to eat. It’s the “dark side” of insulin pump use that gets little attention. The message here is: know how to retrieve your child’s pump history. You may be surprised at what you find. And it may not be extra bolusing.

Often there are just as many skipped or missed boluses.

This brings me to my first rule of insulin pumping:

Pump Rule #1: The pump is no better (or worse) than the human being it’s attached to.

Never forget that.

Announcing a Type 1 Diabetes Practice Based Research Network (T1PBRN)

Thursday, September 27th, 2007

Healthcordia platform illustration as sweetkidsnetwork architecture

Here it is! Making great progress on this front lately and thought I would share the good news w/anyone interested in new paradigms of diabetes care including acceleration of the clinical trials process for new cures, new cure therapies and new devices to assist people with tight blood sugar control.

Announcing the SWEETKIDSNETWORK

Check it out online at www.sweetkidsnetwork.org and check back often to see progress announcements and to find out about research trials looking to recruit patients from the Sweet Kids Network.

Worldwide Abbott Glucose Meter Correction Notice (FDA)

Tuesday, September 11th, 2007

Recall — Firm Press Release
Urgent: Abbott Notifies Users of Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® Blood Glucose Meters to Check Display Screens

 

 

Not sure why it took me this long to find out about it?

 

 

From the FDA (also more info available at Abbott Diabetes):

 

 

FOR IMMEDIATE RELEASE — Alameda, CA — August 31, 2007 — Abbott is initiating a worldwide medical device correction for users of its Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® blood glucose meters manufactured after January 31, 2007. If the meter is dropped on a hard surface, part or all of the display screen may not work properly or may appear blank, which could result in an inability to view blood glucose test results. The inability to generate blood glucose results could result in significant risk for hypoglycemia or hyperglycemia. Users of these meters who note that the display screen is not working properly should immediately stop using their meter as referenced in the User Guide and call Abbott Diabetes Care customer care for assistance at 1-877-844-4404. Through internal testing, Abbott Diabetes Care has found that when recently produced meters are dropped onto a hard surface, part of the display can be jarred or disconnected, thereby making it difficult to read the lot number or date information, or causing the screen to appear blank. No injuries have been reported to date.

Patients should keep their glucose meters in the wallet provided to offer additional protection for the meter. If the meter is dropped on a hard surface, patients should immediately perform a meter display check. Instructions on how to do this are detailed in the meter’s Users Guide. If no problems are encountered during the automatic display check, the meter is ready for use. Customers may call Abbott Diabetes Care customer care at 1-877-844-4404 to determine the date their meter was manufactured. Customers may also call customer care if they have questions or need a replacement meter.

Precision Xtra™, Optium, ReliOn® Ultima, Rite Aid® and Kroger® blood glucose meters have been distributed via retail and mail order pharmacies, physician offices and distributors. Abbott is notifying physicians, pharmacists, distributors and registered users by letter.

Blood glucose test strips used with these meters are not affected by this notification.

More information about this notification is available on the company’s website, www.abbottdiabetescare.com.

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Contact:
Tama Antonia Donaldson
(510) 749-5449

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

 

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