[Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy Diabetes care
n8tnv at att.net
Sat Aug 31 14:02:28 UTC 2013
I hope we can get to the bottom of this.
I understand that there are some Talking Meters which require less blood on the strip.
Since it is very hard for me or anyone else for that matter to get enough blood for a reading from me I would like to find a meter which needs less blood.
If anyone knows of a Talking Meter which require less blood than the Prodigy Meter I purchased from NFB in 2011 that would be great.
I mentioned where I got the Meter because I am not sure which one I have at the moment.
----- Original Message -----
From: Mike Freeman <k7uij at panix.com>
To: Diabetes Talk for the Blind diabetes-talk at nfbnet.org
Date: Saturday, August 31, 2013 1:20 am
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.htm#.UhYvg45gcaE.email
> >> The Diabetes Watchdog
> >> To visit our website click here: Diabetes Watchdog
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