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

[Kelly Massaro]

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
_______________________________________________
Diabetes-talk mailing list
Diabetes-talk at nfbnet.org
http://nfbnet.org/mailman/listinfo/diabetes-talk_nfbnet.org
To unsubscribe, change your list options or get your account info for
Diabetes-talk:
http://nfbnet.org/mailman/options/diabetes-talk_nfbnet.org/kellym%40prodigym
eter.com
-------------- next part --------------
A non-text attachment was scrubbed...
Name: WLResponseLetter.pdf
Type: application/pdf
Size: 273660 bytes
Desc: not available
URL: <http://nfbnet.org/pipermail/diabetes-talk_nfbnet.org/attachments/20130905/8e78a068/attachment.pdf>