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

[Bridgit Pollpeter]

And my Prodigy Voice has been fine. I've been using it for years now,
and I rarely have problems, and when I do, it's usually my human error,
smile.

Bridgit

-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf
Of Kelly Massaro
Sent: Thursday, September 05, 2013 3:22 PM
To: 'Diabetes Talk for the Blind'
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued toProdigy
Diabetes care


The Prodigy Voice meter is fine.  There has been NO warning letter
issued regarding the meter.  

Mike Freeman, the NFB President was kind enough to convert Prodigy's
response to text in an earlier post.  

Kelly Massaro
kellym at prodigymeter.com
704-458-9400


-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf
Of d m gina
Sent: Thursday, September 05, 2013 4:11 PM
To: diabetes-talk at nfbnet.org
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
Diabetes care

Does this mean in the future we will no longer be able to use the
prodigy? that we would have to get a different machine? I couldn't tell
you how long I have had my machine, the years fly by quickly.

Original message:
> Vincent,

> I hope this finds you well.

> I have attached a response from Prodigy Diabetes Care regarding the
> FDA warning letter you reference in your post.

> If you have questions, or difficulty opening this letter please let me
know.

> Have a nice day

> Kelly Massaro
> kellym at prodigymeter.com
> 704-458-9400


> -----Original Message-----
> From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On
> Behalf Of Vincent Chaney Jr
> Sent: Friday, August 30, 2013 10:52 PM
> To: NJ-Diabetes-Division; Diabetes Talk for the Blind
> Subject: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy 
> Diabetes care

> 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/ucm360
> 148.ht
> m#.UhYvg45gcaE.email



>> The Diabetes Watchdog



>> To visit our website click here: Diabetes Watchdog
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--
--Dar
skype: dmgina23
  FB: dmgina
www.twitter.com/dmgina
every saint has a past
every sinner has a future

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