Voluntary Recall of Specified Lots of Nova Max® Glucose Test Strips

There is a recall notice out today about specific lots of Nova Max® test strips.

Please see details at:

http://www.novacares.com/news/nova-max-recall.php

In part it says:

WALTHAM, Mass. - July 26, 2013 Diabetes Care today announced it is initiating a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max® Plus™ glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall. 

The company has recently determined that some of the blood glucose test strips contained within the indicated Nova Max Glucose Test Strip lots and Nova Max Plus glucose meter kits may report a false, abnormally high blood glucose result. Those who use, recommend clinically, or sell Nova Max Glucose Test Strips for blood glucose testing should immediately discontinue using or distributing glucose test strips from the recalled lots and catalog numbers. 

A false abnormally high blood glucose result could, under certain conditions, result in an insulin dosing error that could lead to a serious health risk requiring immediate medical attention. 

Customers can check to confirm if they have blood glucose test strips from the affected lots by visiting www.novacares.com/news/nova-max-recall.php or by contacting Nova Diabetes Care customer service at 1-800-681-7390. 

No other product or lot number from Nova Diabetes Care is impacted by this recall. Customers can contact Nova Diabetes Care customer service at 1-800-681-7390 to replace their affected test strip lot or meter kit at no charge.

Other reports state the lots are:

Nova Max Test Strip Recalled Lots

Test Strip Lot Number
1020211346
1020411347
1020611348
1020811350
1020211355
1020212032
1020512087
1020212100
1020212101
1020212153
1020712206
1020212207
1020412255
1020212291
1020912292
1020412341
1020213043
1020213074
1020213109

It is Not OK.

Sometimes, I may be prescient. I know that came as a shock to me too.

Back in 2010 I wrote a piece about medical devices approved by the FDA. In it I joked about the OK Meter saying, “No pretensions of greatness at all. It is just OK.”

Maybe it isn’t so OK.

OK Biotech and Prodigy Diabetes care “Aligned Ownership.” In their announcement they were clear about opportunities with Centers for Medicare and Medicaid Services bidding.

Yesterday Prodigy Diabetes Care was disclosed as the recipient of a FDA warning letter in the FDA press release, “FDA alerts companies to stop illegal sale of treatments for diabetes.”

I strongly urge people with diabetes to read that FDA letter.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm360148.htm
In part it says:

Complaint #598 describes an event in which a patient exhibited symptoms of low blood sugar levels after receiving high (260, 169, and 158 mg/dL) blood glucose results when using your firm’s device. Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL. The information included for complaint # 598 reasonably suggests that your firm’s device may have caused or contributed to a life threatening injury. An MDR should have been submitted for this complaint.

That said:
Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL - And - 

An MDR should have been submitted for this complaint.

That means one was not.

That is NOT OK.

How far below 20mg mg/dl does someone have to go to get a Medical Device Report filed? How much lower can someone go and recover?

 Thanks FDA for the letter.

One question - Does warning mean they are still selling strips to CMS?


If meter accuracy matters to you join the campaign at www.StripSafely.com

iGlucose?

Just saw a link on MacRumors that Apple is hiring folks with health sensor background for the iWatch team. Maybe they should call Terry Gregg and get started on an app for the G5 Dexcom.

May as well pay with the varsity - just saying.

http://www.macrumors.com/2013/07/18/apple-taps-new-hires-in-health-sensors-broad-array-of-internal-experts-for-iwatch-team/

#DSMA Live in Philly

Yo! Philly

Youz should be at 'dis t'ing here. Youz hear?  

Watch to Vote for Scott

Vote Scott.

Watch early and often (and from every IP address you can)

http://scottsdiabetes.com/2013/07/message-exercise-diabetes/



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StripSafely - Tonight.

Every time we test our blood sugar, PWD make crucial, life-sustaining decisions. Are our strips safe? Please take a look at the StripSafely Campaign, aiming to raise the voices in the diabetes online community for blood glucose test strips that are accurate.

Take the quiz. and 

Tune into DSMA Live 'Rents tonight at 9:00 and learn more.

T2D SLGT2 in T2D?

from medpagetoday: 

New Type 2 Drug May Work in Type 1 Diabetes
CHICAGO -- An investigational agent for type 2 diabetes may also work as add-on therapy in type 1 disease, researchers reported here.
http://www.medpagetoday.com/MeetingCoverage/ADA/40091?xid=nl_mpt_DHE_2013-06-26&utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g588371d0r&userid=588371&email=bennet.dunlap@gmail.com&mu_id=5713561

Quick bit on Cgm accuracy.

It is getting better.



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Social Media and The Monster Under the Bed

Join me (and a bunch of other people far more interesting than me) for a special session at the upcoming Children with Diabetes’ Friends for Life conference in Orlando on social media and diabetes support. If you are planning to attend FFL this year, I'd love for you to join us for an exchange between clinical/academic experts and the diabetes online community. If you can't make it to FFL you can join a streaming of the event. DOC members (including your truly) will talk with a panel of clinical/academic experts assembled to specifically to discuss the value of peer-to-peer support and the online community.

Sign up Now!

Participating live or online can help demonstrate the value we in the DOC place on peer to peer social media. If you plan to attend in person, please RSVP by June 28 to P4DC@toniclc.com. (I hope it fills up fast, maybe and early RSVP is better than later.) If you want to join the live stream please fill out this registration. 

We’ll also field questions on Twitter via the #P4DC hash tag on the day of the session.

Here are some more details. 

Partnering for Diabetes Change (P4DC) is a coalition of people living with diabetes and industry representatives aimed at addressing unmet needs in diabetes through community and collaboration. I am honored volunteer my time to help organize P4DC efforts, including this event. I am thrilled that the people at Johnson and Johnson support the community and make things like this possible. P4DC seeks to validate the role of peer support in diabetes management, address the stigma of type diabetes, and ultimately support underserved communities.

You can be a part of the P4DC effort by participating in this live event, and by offering questions either in person or via Twitter. It is P4DC’s hope that through this session, they will be able to make a first step in showcasing the value of the DOC and the importance of social media engagement for patients.

In PA? Call your Senator in Harrisburg.

We need to get legislation out of the education committee and passed to Kids with Diabetes Safe at School. I sent this email to my senator's staff, Eric Pauly. They vote June 19 9:00am. 

Please do too, or call 717 787 6599

EPauly@pasen.gov

Dear Eric, 

Kids should be safe at school. Even kids with diabetes. 

I support safe at school. I have two kids with type 1 diabetes. I intimately know this issue. 

I support SB 871. 

Will Senator Greenleaf? 

As a parent of children with type 1 diabetes, I want to thank the senator for his support of safe at school legislation in previous sessions.  I hear rumors of a flip flop to the nurses union position. I hope not. 

I hope he will continue to support safe at school and vote for 871. It is a bill that allows local school officials and parents to cooperate to provide safe school environments for children with diabetes. 

I know there are many issues in the Commonwealth. I appreciate that your office has show nuanced appreciation for this approach to facilitating parents and schools to work together to keep children safe, in class without a de facto mandate from the capital to micromanage and inflatelocal school board budgets. I appreciate that he has shown leadership on this issue as a sponsor in the past.

It is time to get this bill passed. 

Senator Greenleaf's continued support is an important step in the process. Diabetes requires ongoing vigilance. Diabetes management does not wait for legislative sessions. Unfortunately not all school budgets can expand to provide full time nursing. Local officials and parents should have the flexibility to agree to train a responsible adult to provide the needed diabetes support to help kids stay safe in schools.

Safe includes medically safe. Most of the daily tasks for children with diabetes care now are provided or supervised by parents and other adults who have be trained by diabetes educators. This standard of care can work in schools where there is not full time nursing coverage. SB 871 anticipates that and is supported by the Pennsylvania Medical Society, demonstrating the processes this bill proposes are medically sound.  

There are best practices recommended for diabetes and schools created by the leading health and education professionals. They are in a document called Helping the Student with Diabetes Succeed: A Guide for School Personnel. It was written by the NDEP, a partnership of the National Institutes of Health, the Centers for Disease Control and Prevention, and more than 200 public and private organizations including school administrators, physicians and nurses. 

Not exactly bums. 871 makes the best practices of helping students possible in PA. They are not now. 

The bill is exactly the kind of considered approach needed to support kids with diabetes in schools.

Thank you for your efforts to keep children safe in school.

Let's focus on succeeding.

To help kids succeed in safe schools, I support PA 871. The nurses union is opposed, if the Senator vote with them I expect him to fund the increase in budgets across the state their position will require with the tax revenue non of us want increased. 

Bennet Dunlap