FDA: Nova Recalls 62 Million Nova Max Diabetes Test Strips - News - @ JEMS.com

FDA: Nova Recalls 62 Million Nova Max Diabetes Test Strips

Faulty test strips could lead to dangerous medication errors for patients


U.S. Food and Drug Administration | | Wednesday, July 31, 2013

The U.S. Food and Drug Administration is working with Nova Diabetes Care to recall 21 lots of glucose test strips marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits. Nova Diabetes Care announced a recall on July 26, 2013.

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The recall pertains to certain lots of these test strips distributed in the United States, Canada, Chile, Peru, Argentina, Dominican Republic, Jamaica, Puerto Rico, United Kingdom, Germany, Belgium, Finland, Congo, and Saudi Arabia. As many as 62 million strips may be affected by the recall. Other Nova Diabetes Care products are not affected by the recall.
The test strips under recall may report a false, abnormally high blood glucose result.  Under certain conditions, a false, abnormally high blood glucose level could result in an insulin dosing error, requiring the user to seek immediate medical attention.   
The test strips, which were manufactured from December 2011 to April 2013, are sold in retail stores and online directly to consumers, and are used in health care facilities. The test strips became contaminated with a chemical used during the manufacturing process. The FDA is working with Nova to investigate the problem and prevent it from recurring.
“It is important that patients using these test strips discontinue their use immediately,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “A false reading could result in patient harm and delay critical care.”
Patients and health care professionals should report serious adverse events (side effects) with the device to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone:
    Online: www.fda.gov/MedWatch/report.htm
    Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
    Fax: 800-FDA-0178
    Phone: 800-332-1088

The FDA has provided recommendations for people with diabetes and health care professionals below that explain how to determine whether a particular lot is affected, how to order free replacement strips and precautions to take if consumers must use the recalled strips.
Recommendations for Patients:
Check to confirm if you have blood glucose test strips from the affected lots by visiting www.novacares.com/news/nova-max-recall.php or by contacting Nova Diabetes Care customer service at 1-800-681-7390. Consumers will be directed to return recalled test strips to the company in return for replacement strips at no charge.

Immediately discontinue use of the recalled strips and take the necessary steps to continue to monitor your blood sugar.

Use an alternate method to measure blood glucose (such as a different test system) or purchase at least two weeks worth of new, unaffected strips while waiting for replacement strips.

Continue to test your blood glucose, even if the only test strips available to you are from affected lots. Take the following precautions to reduce the chance of a false reading:

♦ As stated in the Blood Glucose Monitor Owners Guide and Nova Max Glucose Test Strip Product Insert, perform a quality control solution test to confirm that your vial of Nova Max Glucose Test Strips is working correctly. Do not use a test strip vial if control solution results are not within the expected range.

♦ Verify all elevated blood glucose test results that are not consistent with your diabetes history by repeating the test using a new blood glucose test strip from a different vial (if available) or the same vial (if a new vial is unavailable).

♦ Contact your health care provider immediately if your reported blood glucose result(s) are not consistent with your diabetes history, how you feel, or if you think your results are not accurate (higher than expected).   

♦ Pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional.

Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.

Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may have no symptoms at all before they develop unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or a seizure. If you are unable to obtain unaffected strips, you should contact your health care provider for advice on how to treat these symptoms before they occur.
Recommendations for Health Care Professionals:

Immediately discontinue distributing the indicated Catalog Numbers in the attached appendix to patients and collect all samples that are in your possession. 

Call Nova at 1-800-681-7390 for shipment of replacement product.

Recommendations for Pharmacists:

Immediately identify all Nova Max Glucose Test Strips and Nova Max Plus Meter Kits from the indicated Catalog Numbers/Lot Numbers in the attached appendix that you have in inventory and return those for a credit following your normal return procedures.
To determine if you have product being recalled: Call Nova Diabetes Care Customer Service at 1-800-681-7390 to verify the Lot # for Nova Max Glucose Test Strips and Nova Max Plus Glucose Meter Kits.

For more information: Nova Diabetes Care Recall
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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