In July 2003 Diestronic announced it would stop selling its H-Tron v100 and H-Tron plus v100 insulin pumps. The Food and Drug Administration (FDA) found several safety violations, including water ingress, cracks in the case, and short-lived batteries.
H-Tron insulin pumps that have any of these defects can lead to water entering the pump. This, in turn, can result in the unintended delivery of a bolus (concentrated mass of substance), which can cause severe health complications, such as hyperglycemic and hypoglycemic effects.
Symptoms of hypoglycemia include:
- dizziness
- shakiness
- sweating
- hunger
- seizure
- headache
- confusion
- moodiness
- crying
Symptoms of hyperglycemia include:
- frequent urination
- high blood sugar
- high levels of sugar in urine
- increased thirst
