Table 1.
1. Use in patients less than 2 years old |
2. Insertion of sensor in unapproved site: arms, buttocks, back, thigh |
3. Pediatric patient using a receiver approved for adults; and vice versa |
4. Use in pregnancy |
5. Using transmitter past expiration date |
6. Using sensor past expiration date |
7. Use of device while taking medications containing acetaminophen |
8. Improper insertion of transmitter. |
9. Calibration while error symbol is displayed |
10. Calibration during a rapid change in glucose, ie, rise or fall >2 mg/dl/minute |
11. Calibration using a meter to calibrate that is different from the meter used to measure glucose |
12. Calibration using of alternative blood glucose testing sites other than fingertips |
13. Delay of greater than 5 minutes in entering calibration values |
14. Entering calibration values outside the 40-400 mg/dl range |
15. Calibrating less often that every 12 hours |
16. NOT calibrating after experiencing inaccuracies |
Source: MAUDE Database.