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

[d m gina]

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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