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

[Mike Freeman]

I've done a bit of research and it would appear that the warning on the FDA
website itself is legitimate although I'm damned suspicious of the spam
message Vincent and I received.

I confess that I also think some of the criticisms are a bit of pettifoggery
in that I and, I suspect, most blind folks, haven't a clue what the lot
numbers of our strips are and I suspect that almost every meter manufacturer
in the country would flunk the sort of bureaucratic requirements as in
designing "reasonably expect". That doesn't take meter manufacturers off the
hook but it does show that the whole area of meters is pretty slipshod and,
I suspect, will continue to be so until Congress gets over its allergy to
subjecting business to requirements.

Mike Freeman


-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
Mike Freeman
Sent: Friday, August 30, 2013 10:17 PM
To: Diabetes Talk for the Blind
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.ht
m#.UhYvg45gcaE.email
>> 
>> 
>> 
>> The Diabetes Watchdog
>> 
>> 
>> 
>> To visit our website click here: Diabetes Watchdog
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