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

Mike Freeman k7uij at panix.com
Sat Aug 31 19:23:55 UTC 2013



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


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 [])

                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

                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@

  by mail65.opentransfer.com with ESMTPAM; 30 Aug 2013 20:46:12 -0000


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:


The Diabetes Watchdog


To visit our website click here: Diabetes Watchdog
To unsubscribe from our emails click here: Unsubscribe

More information about the Diabetes-Talk mailing list