[Diabetes-talk] Fwd: FDA Warning Letter Issued to ProdigyDiabetes care

[Bill Lewis]

My Prodigy meter works okay.  But I notice the standard for accuracy in test 
readings is 20 points plus or minus.  Mine is better than that, judging by 
my A1C readings every four months.  --  Bill Lewis




-----Original Message----- 
From: d m gina
Sent: Saturday, August 31, 2013 1:44 PM
To: diabetes-talk at nfbnet.org
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to 
ProdigyDiabetes care

If this is true, then why am I doing so well by listening to my readings.
this is the meter that has worked well for me for years.
I question what they have to say.

Original message:
> Greetings to All:

> FYI...

> This FDA information and the link to the letter are an interesting read.
> This may be something to consider if in the plans to buy a meter

> Vincent
> President DAN of New Jersey



> Sent from my iPhone

> Begin forwarded message:

>> From: watchdog at diabeteswatchdog.org
>> Date: August 30, 2013, 4:46:16 PM EDT
>> To: vgc732 at optonline.net
>> Subject: FDA Warning Letter Issued to Prodigy Diabetes care

>> The US Food and Drug Administration (FDA) published a written warning 
>> letter to Prodigy Diabetes Care identifying serious violations for the 
>> Prodigy Blood Glucose Test System, Prodigy Voice Blood Glucose Monitoring 
>> System, Prodigy Autocode Blood Glucose Meter, and Prodigy Pocket devices. 
>> FDA inspected Prodigy facilities and cited numerous violations and 
>> complaints that were not properly reported and that "reasonably suggests 
>> that Prodigy's device may have caused or contributed to a life 
>> threatening injury".  The letter goes onto detail failures in Prodigy's 
>> manufacturing processes, quality control processes, record keeping, and 
>> details test strip lots that were distributed by the company despite 
>> failing to meet accuracy standards.

>> The letter can be read in its entirety on the FDA website: 
>> http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm360148.htm#.UhYvg45gcaE.email



>> The Diabetes Watchdog



>> To visit our website click here: Diabetes Watchdog
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-- 
--Dar
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every saint has a past
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