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

[Veronica Elsea]

Dar, if anything, this probably means that the Prodigy is just fine. This
report is more about the company's paperwork, reporting problems correctly
and so on. Not that FDA warnings aren't serious things, but I don't honestly
see this one as a major problem at this point. Just my initial
interpretation.
Veronica

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-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of d
m gina
Sent: Thursday, September 05, 2013 1:11 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/ucm360148.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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