Medtronic issued a Class I recall of their MiniMed Quick-set® Paradigm Infusion Insulin pump on June 29, 2009. Thousands of diabetic patients use this device to monitor their blood glucose levels and assist them in the control of their glucose levels by delivering doses of insulin on a pre-determined schedule.
RECALL: “Lot 8” Paradigm Quick-Set MiniMed insulin pumps, Reference numbers: MMT-396, MMT-397, MMT-398 and MMT-399.
Q.Why was the pump recalled?
A.The recall of the “Lot 8” Quick-set® Infusion set was due to:
a problem in the manufacturing of the sets where a lubricant clogged the tubes, which prevented the venting of air from the system
The unequal air pressure in the tubes hinders the proper flow of insulin, causing the user to receive too much or too little insulin
Q.What are the adverse effects caused by the recalled lots?
A.This can cause two scenarios:
Scenario 1: Over delivery of insulin
Due to the loss of ambient air pressure, with improper venting, a large bolus of insulin could be suddenly injected, resulting in a dramatic and potentially fatal drop in blood glucose levels.
Symptoms can include the following:
confusion
fainting
dizziness
difficulty speaking
sweating
weakness
hunger
Severe hypoglycemia can also lead to seizures, stroke, coma and death
Scenario 2: Too little insulin is being delivered
The second scenario results from clogging of the vent which prevents equalization of the air pressure at the time of priming of the insulin pump. The patient thinks it is properly primed and assumes the insulin is being delivered as scheduled. A diabetic who may have an elevated blood glucose level of, for example 200 or 250, does not get the required insulin dose. This causes the glucose level to go to 400, 500 or even higher. This results in the patient suffering a hyperglycemic event known as ketoacidosis. These patients are admitted to the hospital and many have to be admitted to the Intensive Care Unit until their blood glucose levels come back to normal.
Symptoms can include the following:
frequent urination
irregular heart beat
shortness of breath
muscle stiffness and aching
nausea and dizziness
If severe, it can lead to arrhythmias, stroke, heart attack, blood clots, decreased consciousness, coma and death.
Medtronic estimated 2% of the 3 million sets did not work properly and approximates this failure adversely affected 60,000 users.
If you, a family member or loved one has used a recalled Medtronic Quick-set® Paradigm Infusion Insulin pump and suffered an injury from an abnormal blood glucose level, please contact Houssiere, Durant & Houssiere so we can help you. Above all, do not dispose of the equipment!
Additional Resources
These articles discuss ketoacidosis, the result of hyperglycemia – when blood sugar gets too high because of a lack of insulin:
http://www.emedicinehealth.com/diabetic_ketoacidosis/article_em.htm
http://www.mayoclinic.com/health/diabetic-ketoacidosis/DS00674/DSECTION=symptoms
http://www.freemd.com/diabetic-ketoacidosis/symptoms.htm
http://diabetesinformationhub.com/DiabeticKetoacidosis_DiabeticKetoacidosisSymptoms.php
These articles discuss hypoglycemia, or low blood glucose:
http://www.emedicinehealth.com/low_blood_sugar_hypoglycemia/article_em.htm
http://diabetes.webmd.com/tc/hypoglycemia-low-blood-sugar-topic-overview
http://www.nlm.nih.gov/medlineplus/news/fullstory_86194.html
http://www.uihealthcare.com/topics/diabetes/hypoglycemia.html
