Medtronic richiama alcuni set d'infusione Quick-Set® Sicurezza Diabete Libero, un punto fermo in mare aperto

rita ha scritto "L'FDA annuncia che Medtronic, Inc. ha ritirato circa 3 milioni di set di infusione di insulina Quick-Set ® a causa di un difetto di fabbricazione che può comportare la dose sbagliata di insulina. I set di infusione sono utilizzati con pompe di insulina MiniMed Paradigm.

Medtronic ha spiegato che c'è stato un difetto di fabbricazione dei tubi utilizzati per i set d'infusione Quick-Set ®, denominato "Lotto 8", che non può consentire alla pompa di insulina di erogare alla pressione corretta.
Ciò potrebbe comportare una maggiore o minore erogazione di insulina e può provocare danni gravi o morte.

Fonte: http://www.earthtimes.org/articles/show/medtronic-inc-recalls-quick-setreg-infusion-sets,1082607.shtml
Traduzione a cura di: Rita

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Medtronic, Inc. Recalls Quick-Set® Infusion Sets

Medtronic, Inc. recalled some 3 million Quick-Set ® Insulin Infusion sets due to a manufacturing defect that may result in the wrong dose of insulin to patients. The infusion sets are used with MiniMed Paradigm Insulin Pumps. Read on for more information.

(PRWEB) December 9, 2009 -- The U.S. Food and Drug Administration (FDA) announced that Medtronic, Inc. issued a Class I recall of their Quick-Set® Insulin Infusion sets due to a manufacturing defect, July 10, 2009. Medtronic estimated that at least 60,000 out of 3 million infusion sets could be affected. An infusion set is a thin plastic tube used to deliver a correct dose of insulin from an insulin pump to a diabetes patient and is typically replaced every three days. The recalled infusion sets are used with MiniMed Paradigm Insulin Pumps.

Medtronic explained that there was a defect in the manufacture of the tubing used in the Quick-Set® infusion set, referred to as “Lot 8,” which may not allow the insulin pump to vent air pressure properly. This could result in the delivery of too much or too little insulin and can cause serious injury or death.

Houssiere, Durant & Houssiere, LLP's research shows that doctors treating diabetes state that too little insulin causes patients' blood glucose level to rise, resulting in frequent urination, muscle stiffness, aching, nausea and dizziness. If uncorrected, the blood sugar can rise to a dangerously high (hyperglycemic) level resulting in Ketoacidosis, coma and death. On the other hand, over delivery of insulin may cause patients to experience a condition known as hypoglycemia (low blood sugar), equally as serious. Doctors report that low blood sugar can result in confusion, fainting, dizziness, difficulty speaking, sweating, weakness and hunger. Severe hypoglycemia can lead to seizures, coma or even death. Houssiere, Durant & Houssiere, LLP's research is based on findings from medical doctors who treat diabetes.

Houssiere, Durant & Houssiere, LLP is filing suite in federal court in Houston, Texas on behalf of six injured plaintiffs. Case number 4:09-cv-03854 was filed against Medtronic MiniMed, Inc. on Nov. 30, 2009, with the United States District Court, Southern District of Texas, Houston Division.

Medtronic lawyers at Houssiere, Durant & Houssiere, LLP are actively investigating this reported defect and its results to patients and clients. Further information may be obtained from Houssiere, Durant & Houssiere, LLP 1990 Post Oak Blvd., Suite 800, Houston, Texas 77056 or by calling (888) 881-8100. You should maintain any unused infusion sets.

12/2009"