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.