[Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy Diabetes care
Bridgit Pollpeter
bpollpeter at hotmail.com
Sat Aug 31 16:30:57 UTC 2013
I've not experienced problems with my Prodigy Voice.
-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf
Of cheryl echevarria
Sent: Saturday, August 31, 2013 6:24 AM
To: Diabetes Talk for the Blind
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
Diabetes care
Mike after reading this and going on to the FDA.gov website, Prodigy has
been inspected and warned and fined for awhile on these issues.
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> From: k7uij at panix.com
> Date: Fri, 30 Aug 2013 22:17:12 -0700
> To: diabetes-talk at nfbnet.org
> Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
Diabetes care
>
> I'm going to research this a bit before endorsing this to see that it
> is not a bit of industrial sabotage or mischief. I got a copy also
and, frankly, I'm a bit cautious. If the warning pans out, however, we
may have to put our collective thinking caps on to figure out how to
proceed as the Solus V2 isn't on the formulary of many insurance
carriers yet.
> Mike freeman
>
> On Aug 30, 2013, at 19:52, Vincent Chaney Jr <vgc732 at optonline.net>
> wrote:
>
> > 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/ucm
> >> 360148.htm#.UhYvg45gcaE.email
> >>
> >>
> >>
> >> The Diabetes Watchdog
> >>
> >>
> >>
> >> To visit our website click here: Diabetes Watchdog
> > _______________________________________________
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> > anix.com
>
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