[Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy Diabetes care
k7uij at panix.com
Sat Aug 31 05:17:12 UTC 2013
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.
On Aug 30, 2013, at 19:52, Vincent Chaney Jr <vgc732 at optonline.net> wrote:
> Greetings to All:
> 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
> 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.htm#.UhYvg45gcaE.email
>> The Diabetes Watchdog
>> To visit our website click here: Diabetes Watchdog
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