Back in 2010 I wrote a piece about medical devices approved by the FDA. In it I joked about the OK Meter saying, “No pretensions of greatness at all. It is just OK.”
Maybe it isn’t so OK.
OK Biotech and Prodigy Diabetes care “Aligned Ownership.” In their announcement they were clear about opportunities with Centers for Medicare and Medicaid Services bidding.
Yesterday Prodigy Diabetes Care was disclosed as the recipient of a FDA warning letter in the FDA press release, “FDA alerts companies to stop illegal sale of treatments for diabetes.”
I strongly urge people with diabetes to read that FDA letter.
In part it says:
Complaint #598 describes an event in which a patient exhibited symptoms of low blood sugar levels after receiving high (260, 169, and 158 mg/dL) blood glucose results when using your firm’s device. Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL. The information included for complaint # 598 reasonably suggests that your firm’s device may have caused or contributed to a life threatening injury. An MDR should have been submitted for this complaint.
Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL - And -
That means one was not.
That is NOT OK.
How far below 20mg mg/dl does someone have to go to get a Medical Device Report filed? How much lower can someone go and recover?
Thanks FDA for the letter.
One question - Does warning mean they are still selling strips to CMS?
If meter accuracy matters to you join the campaign at www.StripSafely.com