[Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy Diabetes care
n8tnv at att.net
Sat Aug 31 19:32:34 UTC 2013
It's not every meter. Some meters have the problem. If it was every meter there would have been a human outcry a long time ago.
The letter to Prodigy shows that the problem is related to Quality Control.
Some people probably have no problem with their meter because it is one of the ones which work well.
----- Original Message -----
From: d m gina <dmgina at samobile.net>
To: diabetes-talk at nfbnet.org
Date: Saturday, August 31, 2013 2:44 pm
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy Diabetes care
> If this is true, then why am I doing so well by listening to my readings.
> this is the meter that has worked well for me for years.
> I question what they have to say.
> Original message:
> > 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.htm#.UhYvg45gcaE.email
> >> The Diabetes Watchdog
> >> To visit our website click here: Diabetes Watchdog
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