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

[Mike Freeman]

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

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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

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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

 

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