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

[Mike Freeman]

Ahem... I'm not nfb President. :-) 
Mike 

On Sep 5, 2013, at 13:21, Kelly Massaro <kellym at prodigymeter.com> wrote:

> 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
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> every saint has a past
> every sinner has a future
> 
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