Table 3.
Adverse events reported to FDA* and to TuAnalyze†
| FDA, N (%) | TuAnalyze, N (%) | |
|---|---|---|
| Total events | 20 423 | 75 |
| Device malfunction | 15 795 (77.3) | 39 (52.0) |
| User injury | 4408 (21.6) | 3 (4.0) |
| Type of device | ||
| Blood glucose monitor | 13 108 (64.2) | 10 (13.3) |
| Continuous glucose monitor | 1210 (5.9) | 24 (32.0) |
| Insulin pump | 7260 (35.5)* | 35 (46.7) |
| Insulin pen | 21 (0.1) | 6 (8.0) |
| Interval between event and report available | 8100 (39.7) | 75 (100) |
| Less than 4 weeks | 6063 (74.9) | 32 (42.7) |
| 1–6 months | 1906 (23.5) | 23 (30.7) |
| Greater than 6 months | 131 (1.6) | 20 (26.7) |
| Events with patient outcome information | 4579 (22.4) | 75 (100) |
| Required intervention | 2225 (48.6) | 40 (53.3) |
| Required hospitalization | 1090 (23.8) | 5 (6.7) |
*U.S. Food and Drug Administration.
†For FDA data available in the Manufacturer and User Facility Device Surveillance (MAUDE) database, devices that include an insulin pump and integrated continuous glucose monitors are counted as both types of device.