[Diabetes-talk] FW: FDA Warning Letter Issued to Prodigy Diabetescare

[Sandi Ryan]

I didn't check it out using the URL provided.  I went to my browser and 
typed in www.fda.gov only, then searched "Warning Letters - Prodigy."  The 
first two search items related to the e-mail we received, and the URL for 
them was the same as in the e-mail.

I hope this helps.

Sandi

----- Original Message ----- 
From: "Mike Freeman" <k7uij at panix.com>
To: "Diabetes Talk for the Blind" <diabetes-talk at nfbnet.org>
Sent: Saturday, August 31, 2013 2:23 PM
Subject: [Diabetes-talk] FW: FDA Warning Letter Issued to Prodigy 
Diabetescare


> All:
>
>
>
> I'll check this out. However, I don't like the URL for the FDA warning. 
> Nor
> do I like the Internet headers which show that this email originated in
> Europe using an email address that may well be spoofed and causing the 
> email
> to be distributed by a European Internet provider via relay or similar
> mechanism, rather than being from an Internet server within the United
> States whose email shows it is coming from the registered domain
> <diabeteswatchdog.org>. Note also that the email caused Panix, my ISP, to
> assign the message id, rather than having it be carried intact, from the
> originating email address, whatever it really is. Note that I, the
> addressee, am shown not as the direct intended recipient, but as "for
> k7uij at panix.com". In other words, we see here the usual tactics of 
> spammers.
> From my perspective, were this a true warning, the originator would have 
> had
> the self-respect and honesty to originate the message from a 
> straightforward
> email address here in the U.s. whose domain is registered here. I haven't
> done a WHOIS on this yet and I'll certainly check out the warning. But I 
> can
> assure you I'll switch to in-private browsing so I'm protected before 
> doing
> so.
>
>
>
> The warning may well be legitimate; I'll comment on it in several messages
> to come.
>
>
>
> But remember that we don't except anonymous reports of anything within 
> NFB:
> if reporters haven't the guts to put their names on their reports, then 
> they
> don't deserve credibility.
>
>
>
> Now, below my name, are the Internet headers. Read carefully.
>
>
>
>
>
> Mike Freeman
>
>
>
> From watchdog at diabeteswatchdog.org Fri Aug 30 16:46:12 2013
>
> Lines: 29
>
> Return-Path: <watchdog at diabeteswatchdog.org>
>
> X-Original-To: k7uij at panix.com
>
> Delivered-To: k7uij at panix.com
>
> Received: from mail2.panix.com (mail2.panix.com [166.84.1.73])
>
>                by mailbackend.panix.com (Postfix) with ESMTP id C1FF528BCB
>
>                for <k7uij at panix.com>; Fri, 30 Aug 2013 16:46:12 -0400 
> (EDT)
>
> Received: from mail65.opentransfer.com (mail65.opentransfer.com
> [76.162.254.65])
>
>                by mail2.panix.com (Postfix) with ESMTP id 9F3861F083
>
>                for <k7uij at panix.com>; Fri, 30 Aug 2013 16:46:12 -0400 
> (EDT)
>
> Received: (qmail 30333 invoked by uid 399); 30 Aug 2013 20:46:12 -0000
>
> Received: from unknown (HELO Bob-Laptop)
> (watchdog at diabeteswatchdog.org@173.10.255.42)
>
>  by mail65.opentransfer.com with ESMTPAM; 30 Aug 2013 20:46:12 -0000
>
> X-Originating-IP: 173.10.255.42
>
> MIME-Version: 1.0
>
> From: watchdog at diabeteswatchdog.org
>
> To: k7uij at panix.com
>
> Date: 30 Aug 2013 15:46:14 -0500
>
> Subject: FDA Warning Letter Issued to Prodigy Diabetes care
>
> Content-Type: text/html; charset=us-ascii
>
> Content-Transfer-Encoding: quoted-printable
>
> X-Antivirus: avast! (VPS 130830-0, 08/30/2013), Outbound message
>
> X-Antivirus-Status: Clean
>
> Message-Id: <20130830204612.9F3861F083 at mail2.panix.com>
>
>
>
>
>
> From: watchdog at diabeteswatchdog.org [mailto:watchdog at diabeteswatchdog.org]
> Sent: Friday, August 30, 2013 1:46 PM
> To: k7uij at panix.com
> 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
> <http://www.diabeteswatchdog.org/>
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> <http://www.diabeteswatchdog.org/contact.html>
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