Home care is generally directed toward preventing diabetic elevated high blood sugar.If you have type 1 diabetes, you should monitor your blood sugars at least 3-4 times a day.Concentrations of whole blood glucose were measured using two different glucose oxidase impregnated test-strips. The recordings obtained by one observer with Dextrostix were compared with those recorded by an independent observer using BM Test Glycemie 20-800 strips.
Dextrostix need a reflectance meter (Ames-Eyetone or Hypocount) for accurate quantitation whereas the BM Test Glycemie 20-800 strips can be read by eye alone. These two semi-quantitative methods for self-monitoring of blood glucose gave similar results over the range 2.2 to 22.0 mmol glucose per litre. The BM Test Glycemie 20-800 strips however are technically easier to use than the Dextrostix in that there is less error if the operator fails to comply exactly with instructions regarding exposure time to the drop of blood. They furthermore eliminate the need for a reflectance meter.
A series of studies were carried out to assess the usefulness and accuracy of measuring blood sugar levels in a tropical medical practice using an enzyme test strip ("Dextrostix"). The results showed that the method is simple, accurate and reproducible, especially when the colour changes on the strips are interpreted electronically by the reflectance meter or Eyetone instrument.
The results are independent of packed cell volume. Sequestrene-containing blood samples maintain a constant level of glucose for 5 hours. The Eyetone can be used for approximate determination of blood glucose levels greater than 400 mg per 100 ml by exposing the strips to blood for only 30 seconds and multiplying the result by two. Where there is no mains supply, the instrument can be operated from a car battery.
The U.S. Food and Drug Administration (FDA) alerted the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. These test strips are used by people with diabetes to measure their blood glucose. Today's announcement provides two additional lot numbers that are included in the distribution of counterfeit products, along with descriptions of how to identify them.
The counterfeit test strips are:
One Touch Basic®/Profile® (lot #272894A, 2619932, 2606340, and 2615211 (new)) test strips; and,
One Touch Ultra® (lot #2691191 and 2691261 (new)) test strips.
The counterfeit test strips potentially could give incorrect blood glucose values--either too high or too low--which might result in a patient taking either too much or too little insulin and lead to serious injury or death.
LifeScan alerted FDA of the counterfeit test strips. The FDA continues to investigate the matter, including whether there have been any adverse events associated with this counterfeit product.
Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may contact Lifescan, Inc. at 1-866-621-4855. Consumers who have discarded the outer box or do not know the lot number of their test strips should stop using those test strips and replace them.
The counterfeit test strips were distributed to pharmacies and stores nationwide by various distributors.
How to Identify
For complete information on how to identify the counterfeit test strips, please check Lifescan's web site at www.lifescan.com/company/about/press/counterfeit/.
The following characteristics may help to identify the counterfeit test strips:
Counterfeit One Touch Basic/Profile Test Strips, lot numbers 272894A, 2619932, and 2606340
The lot number 272894A, 2619932, or 2606340 appears on the outer carton and on the inner container (vial).
The outer carton is written in multiple languages including English, Greek and Portuguese.
The outer carton is labeled as 50-Count One Touch (Basic/Profile) Test Strip packages
The bottom of the outer carton does not include an NDC number.
Counterfeit One Touch Basic/Profile Test Strips, lot number 2615211
The lot number 2615211 appears on the outer carton and on the inner container (vial).
The outer carton is written in English.
The outer carton is labeled as 50-Count One Touch (Basic/Profile) Test Strip packages.
A picture of a hand appears on the test strip displayed on the outer carton.
The inner container is labeled as “plasma-calibrated”.
Counterfeit One Touch Ultra Test Strips, lot numbers 2691191 and 2691261
The lot number 2691191 or 2691261 appears on the outer carton and on the inner container (vial).
The outer carton and the inside container (vial) are written in both English and French.
The outer carton is labeled as 50-Count One Touch Ultra Test Strip packages.
The bottom of the outer carton does not include an NDC number.
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