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Tuesday, July 14, 2009

Medtronic Issues Voluntary Recall of 3 Million Insulin Pump Infusion Kits

Last week, Medtronic issued a recall of about 3 million infusion sets designed for use with the company's MiniMed Paradigm insulin pumps. The recall was issued because about two percent of the sets (about 60,000) may have been affected by a manufacturing defect and may not work properly. When the infusion sets work improperly, it may result in the pump delivering too little or too much insulin. For people who depend on these pumps, the result may be serious injury or death.

The infusion set is the thin plastic tube that delivers insulin from the pump to the diabetes patient. They are replaced frequently by the patient.

To find out whether your Quick-Set infusion sets are affected by this recall, look for the reference number and lot number on the label of the package or the individual infusion set packaging. The reference number is in the middle left of the label next to the letters "REF." Four different reference numbers are affected by the recall: MMT-396, MMT-397, MMT-398, and MMT-399. The lot number is located directly under the reference number, nexted to the boxed word "LOT." It is a seven-digit number. All affected infusion kits have lot numbers beginning with the number 8 (8XXXXXX).

If a person with diabetes gets too little insulin, they may develop hyperglycemia, which can lead to ketoacidosis and a diabetic coma. Regular insulin users may detect hyperglycemia with a regular blood glucose level test. You should also look out for these symptoms of ketoacidosis:

  • Elevated thirst

  • Frequent urination

  • Tiredness

  • Dry or flushed skin

  • Nausea or vomiting

  • A fruity odor on the breath

  • Confusion or shortened attention span

On the other hand, if a person gets too much insulin, they can suffer from hypoglycemia, with these symptoms:

  • Shakiness or dizziness

  • Sweating

  • Pale skin

  • Clumsy movements or seizures

  • Sudden, excessive hunger

  • Behavioral or mood changes

A person can also pass out from hypoglycemia. Both conditions can be emergencies and should be treated when suspected.

If you or a loved one has experienced any adverse effects as a result of these or other defective medical devices, schedule a consultation with a personal injury lawyer at The Cochran Firm today to learn whether you may be eligible for compensation for your injuries.

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posted by Benjamin A. Irwin at 12:48 PM

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