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

Mike Freeman k7uij at panix.com
Sat Aug 31 20:17:26 UTC 2013


Yup; you're correct. This isn't really new. What *is* new is the spam!

Mike


-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
cheryl echevarria
Sent: Saturday, August 31, 2013 4:24 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/ucm360148.ht
m#.UhYvg45gcaE.email
> >> 
> >> 
> >> 
> >> The Diabetes Watchdog
> >> 
> >> 
> >> 
> >> To visit our website click here: Diabetes Watchdog
> > _______________________________________________
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