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When using the Prodigy No Coding Blood Glucose Monitoring System, it's important to be aware of certain safety considerations to ensure accurate readings and maintain your health:

Accuracy Concerns: Studies have indicated that the Prodigy AutoCode meter may not always provide results within the acceptable error margin. In one study, approximately 25% of readings were outside the ±20% error margin compared to laboratory results. This overestimation could lead to untreated or undertreated hypoglycemia, posing significant safety concerns.

Device Malfunctions: There have been reports of the Prodigy AutoCode meter failing to provide readings, which in some cases led to adverse health events. For instance, a user experienced loss of consciousness after being unable to obtain a blood glucose reading, requiring emergency medical attention.

FDA Warnings: The FDA has issued warnings to Prodigy Diabetes Care regarding violations in medical device reporting and quality systems. These issues included inadequate processes for timely reporting and handling of manufacturing problems or product complaints.

User Safety Instructions:

• Single-Patient Use: The Prodigy meter, test strips, lancets, and lancing device are intended for use by a single individual. Sharing these devices can pose a risk of transmitting blood-borne pathogens such as Hepatitis B or HIV.

• Supervision: Close supervision is necessary when the device is used by, on, or near children, handicapped persons, or invalids.

• Proper Use: Use the device only for its intended purpose as described in the manual. Do not use test strips and control solutions that are not supplied by Prodigy.

• Device Condition: Do not use the device if it is not working properly or if it has suffered any damage.

• Reading Instructions: Before using the product to test your blood glucose, read all instructions thoroughly and practice the test. Perform all quality control checks as directed and consult with a diabetes healthcare professional if needed.

• Choking Hazard: Keep the test strip vial away from children; the vial cap and the test strips can be a potential choking hazard. Never chew or swallow a test strip. If this occurs, seek medical assistance immediately.

Health-Related Information:

• Dehydration: Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.

• Blood Glucose Levels: Test results below 60 mg/dL (3.3 mmol/L) indicate low blood glucose (hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L) indicate high blood glucose (hyperglycemia). If your results are below 60 mg/dL or above 240 mg/dL, repeat the test. If the results are still outside this range, consult your healthcare professional immediately.

• Critical Conditions: Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state. Critically ill patients should not be tested with blood glucose meters.

By adhering to these safety guidelines and being aware of potential risks, you can use the Prodigy No Coding Blood Glucose Monitoring System more effectively and safely.

The Prodigy No Coding blood glucose meters, including models like the Prodigy AutoCode® and Prodigy Voice®, are designed to provide accurate blood glucose readings without the need for manual coding. These devices utilize Glucose Oxidase technology, which is known for its accuracy and is not affected by substances like maltose that can lead to falsely elevated readings.

However, certain factors can influence the accuracy of blood glucose measurements. For instance, using expired test strips can result in inaccurate readings. It's essential to always check the expiration date on your test strips and avoid using them past this date.

Additionally, some medications and health conditions can affect blood glucose levels and, consequently, the readings obtained from glucose meters. For example, elevated blood triglycerides, reducing substances such as uric acid and ascorbic acid at normal blood concentrations, or medications like Acetaminophen, dopa, Methyldopa, L-dopa, and Tolbutamide at normal blood concentrations should not significantly affect the results.

To ensure the most accurate readings, it's recommended to perform regular control solution tests. This involves using a control solution to verify that your meter and test strips are functioning correctly. It's also advisable to consult with your healthcare professional about any medications you're taking and how they might impact your blood glucose readings.

By being aware of these factors and taking appropriate precautions, you can trust the readings from your Prodigy No Coding blood glucose meter to effectively manage your diabetes.