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

COLLEEN ROTH n8tnv at att.net
Sat Aug 31 19:38:32 UTC 2013


Hi Mike,
Thank you, I didn't go check out the email address.
THAT is why I said we would know more on Tuesday when phone calls can be made.
However I was surprised the other day when Prodigy Talking Meters were advertised for $10.00.
I can't remember where, but I thought that was amazing.
I am sure we will have an answer after the holiday so I think people shouldn't panic.
Also there is a time frame for the letters concerning the every-reader.
Colleen Roth



----- 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 3:26 pm
Subject: [Diabetes-talk] FW: FDA Warning Letter Issued to Prodigy Diabetes care

>
>
> 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 Udds. 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 mailbleb.panix.com (mailbleb.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 com0400 (EDT)
> 
> Received: from mailblefe.opentransfer.com (mailblefe.opentransfer.com
> [76.162.254.65])
> 
>                 by mailbleb.panix.com (Postfix) with ESMTP id 9F3861F083
> 
>                 for <k7uij at panix.com>; Fri, 30 Aug 2013 16:46:12 com0400 (EDT)
> 
> Received: (qmail 30333 invoked by uid 399); 30 Aug 2013 20:46:12 com0000
> 
> Received: from unknown (HELO Bob-Laptop)
> (watchdog at diabeteswatchdog.org@173.10.255.42)
> 
>   by mailblefe.opentransfer.com with ESMTPAM; 30 Aug 2013 20:46:12 com0000
> 
> 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 com0500
> 
> 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#.Uhallyvg45gcaE.email 
> 
>  
> 
> The Diabetes Watchdog
> 
>  
> 
> To visit our website click here: Diabetes Watchdog
> <http://www.diabeteswatchdog.org/> 
> To unsubscribe from our emails click here: Unsubscribe
> <http://www.diabeteswatchdog.org/contact.html> 
> 
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