From lawyer Rob Bunch:
The U.S. Food & Drug Administration (FDA) is working to reduce risks from dangerous problems that affect what it described as tens of thousands of diabetics. While the FDA has not provided specific insulin pump manufacturers names in its report, there are known insulin pump makers, including Medtronic Inc, Roche Holding AG, and Johnson & Johnson.
According to the FDA panel papers, here are"Device Problems:"
The most frequently reported device problem in MDR’s related to insulin infusion pumps was ‘unknown,’ and the top five reporters identified “unknown” in 5421 of 16640 reports (19.7% of reports). The second most frequent device problem reported was “replace,” which accounted for 2385 entries (9% of reports).
Patient Problems included:
The most frequently reported patient problems were 1) hospitalization, and 2) blood glucose high. Of the 16640 MDRs from the top five manufacturers, hospitalization was identified in 7967 reports (21% of reports) while blood glucose was identified in 6236 reports (16.6% of reports). The other most frequently reported patient problems reported were:
Diabetic Ketoacidosis (8% of reports)
Hyperglycemia (8% of reports)
Treatment with medication (6% of reports)
Blood glucose low (4.7% of reports)
Therapy/non‐surgical treatment (4% of reports)