Johnson & Johnson Recall: Blood Glucose Meters

by The Rothenberg Law Firm LLP
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In March 2013, LifeScan, a division of Johnson & Johnson, announced a voluntary recall and replacement of approximately 90,000 blood glucose meters in the United States and nearly 2 million meters worldwide. According to the Johnson & Johnson website, the particular meter affected in the United States is the OneTouch® Verio® IQ meter. Other LifeScan products in the United States have not been affected by the recent recall.

Outside of the United States, three different brands are being recalled;

1) OneTouch® Verio® IQ;

2) OneTouch® Verio® Pro; and

3) OneTouch® Verio® Pro+.

What is the wrong with the OneTouch® Verio® products?

At extremely high blood glucose levels, specifically 1024 milligrams per deciliter (mg/dL) and above, the OneTouch® Verio® IQ blood glucose meter will not display a warning of the extremely high blood glucose level. Instead, the meter will shut itself off.

Outside the United States, the recalled products will also malfunction at very high blood

glucose level readings by way of “incorrect glucose value display or record storage.”

What is the risk of injury for users?

When a blood glucose level of 1024 mg/dL occurs, an individual is at a serious risk of acute hyperglycemia. If acute hyperglycemia is left untreated, it can lead to ketoacidosis (dangerously high levels of ketones built up in a person’s blood) or Hyperosmolar Hyperglycemic Nonketotic Syndrom (HHNS). Both ketoacidosis and HHNS are serious emergencies that require immediate medical attention.

Because the defective blood glucose meters simply turn off at such high levels of blood glucose, users who are not aware of the malfunction may not be aware of their life-threatening situation and simply believe that their meter shut off for a different reason. Treatment may be delayed or an incorrect diagnosis might be made, possibly resulting in serious health problems or even death.

To prevent the development of serious complications from hyperglycemia, users of blood glucose meters should always be aware of early symptoms of possible hyperglycemia - even if their meter reading is normal.

Such symptoms include:

  • Polydipsia (frequent or excessive thirst)
  • Headaches
  • Polyphagia (frequent, pronounced hunger)
  • Difficulty concentrating
  • Blurred vision
  • Polyuria (frequent urination)
  • Fatigue (weak, tired feeling)
  • Weight loss
  • Blood sugar more than 180 mg/dL

If hyperglycemia in diabetics is prolonged, it may result in:

  • Cardiac Arrhythmia
  • Vaginal and skin infections
  • Slow-healing cuts and sores
  • Decreased vision
  • Nerve damage causing painful, cold or insensitive feet, loss of hair on the lower extremities, and/or erectile dysfunction
  • Stomach and intestinal problems such as chronic constipation or diarrhea
  • Damage to your eyes, blood vessels, or kidneys               

What should LifeScan OneTouch® Verio® IQ users do?

In the United States, users can immediately arrange to receive a replacement blood glucose meter free of charge simply by calling LifeScan Customer Service at (800) 717-0276, Monday through Sunday, between 8:00 a.m. and 10:00 p.m. Eastern Standard Time. Patients who are aware of the recall and the specific malfunction of the device may continue to use their existing meters while they wait for a replacement. However, LifeScan advises that if the original blood glucose meter suddenly shuts off during testing, you should contact a medical professional as soon as possible because this could signify life-threatening extreme hyperglycemia. Users can learn more about the recall on OneTouch's website.

Johnson & Johnson issued a statement ensuring consumers that the health and safety of their customers and patients is their number one priority. The company has reported the malfunction and recall to all registered users of the blood glucose meter, the Food and Drug Administration, and to healthcare providers, distributors, and pharmacies where this device is sold. Fortunately, this malfunction was discovered before any injuries or adverse events were reported, and hopefully the recall will prevent any future injury. In the event that you experience an injury from a faulty device, call a medical products attorney today.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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