Table 3.
Examples of Device-Related Adverse Events in Hospitalized Children 1–12 Years of Age
| Age | Gender | Patient Problem | Reported Problem | Pump Evaluation |
|---|---|---|---|---|
| 35 months | f | Hyperglycemia | The ACT button did not respond properly | Pump operated OK but moisture on keypad |
| 7 | m | Hypoglycemia, seizures | Parent stated that she gave too much correction before going to bed | Pump not returned Use error |
| 8 | m | Hypoglycemia | Family uncomfortable with pump and wants replacement | Pump tested OK |
| 8 | m | Hyperglycemia, DKA | Pump not correct size for body | Battery was reported to be out of limit; pump tested OK |
| 8 | m | Hyperglycemia, DKA | Parent did not understand pump performance | Pump not returned |
| 8 | m | Hyperglycemia, DKA | Parent not familiar with pump operation | Pump not returned Education needed |
| 9 | f | Hyperglycemia, DKA | Nondelivery during the middle of the night | Pump not returned |
| 9 | f | Hyperglycemia, DKA | Numerous nondelivery alarms | Pump not returned |
| 10 | m | Hyperglycemia | Hospital and family did not want to troubleshoot | Pump not returned |
| 11 | f | Hyperglycemia | Bent cannula, which came out during sleep; two hospitalizations | Pump not returned |
| 11 | m | Hypoglycemia | Parent activated the ACT button with pump in prime mode | Pump not returned Use error |