Reporting CGMS issues to the FDA
The FDA has a new approach for reporting problems with blood glucose meters and continuous glucose monitoring systems (CGMS).Once a glucose meter or a CGMS goes into widespread use, unforeseen problems may arise because FDA's approval process cannot always detect adverse events that are rare or related to the clinical use of the device or the users’ techniques and skills. FDA also cannot always detect manufacturing problems or problems with the product labeling (including instructions for use) after the device is on the market.If you use any of these systems they'd like to hear from you when you encounter any of the following type of problems.
Device problems including
- reagent or instrument failure
- defects in product design
- product instability
- any other device problems that compromise patient health or safety
- failure to perform according to performance characterized in package insert
- incorrect test results that cause or contributed to an incorrect patient diagnosis and/or treatment
- inadequate and/or misleading labeling or confusing user instructions
Use-related problems - inadequate packaging or poor package design
- any other user problems that compromise patient health or safety
Finally a way to get attention to system issues that annoy you! Full details on the FDA website.
posted by Bernard @ 7:51 PM
2 Comments:
Thanks for stopping by my blog Bernard. I'm so glad SOMEONE understands how excited I am. I read your super power blog, very funny and TRUE! I DO have a copy of the CGM guide, though I'm ashamed to admit I haven't cracked it yet. It's been a very busy week! Thanks for reminding me that I need to do so, though!
Sometimes it seems like the CGMs are still in beta testing!
Anyway, thanks for the welcome! I look forward to checking out your posts :)
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