Just when we thought we were finished this year with recalls of blood glucose home testing devices and supplies, a new one surfaced last week.
This most recent recall pertains to certain lots of Abbott glucose test strips that provide incorrect low readings of blood glucose levels. As a result, the patient may be inclined to adjust their glucose management, thinking that their low glucose levels need to be raised, when they may already be higher than normal, resulting in hyperglycemia.
Abbott has announced the recall in the United States of of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test strips. These test strips produce erroneous results only when used with the company’s FreeStyle Blood Glucose Meter and FreeStyle Flash Blood Glucose Meters, which were last manufactured in 2010. Also impacted in the recall is the OmniPod Insulin Management System. The same strips when used with newer test devices, reportedly produce correct glucose measurements.
The expiration dates for the Abbott test strips are between May 2014 and March 2015 and their lots are listed.
John Wilkinson, director of medical devices at the British Medicine and Healthcare Products Regulatory Agency is quoted as saying “While three lots of the test strips have been affected by the manufacturing fault this problem has been resolved and there is no evidence that any patients in the UK have been adversely affected by the faulty test strips” He advises that people who have FreeStyle Lite Blood Glucose Test Strips “should continue to test their blood sugar but should be mindful that they could give a misleading low reading.” In the U.S., Abbott has notified anyone possessing strips with affected lots to call Abbott’s diabetes care customer service at 888-736-9869 and arrange for replacement of the strips at no cost.
During the summer, Nova Diabetes announced a recall of 21 lots of their Nova Max Glucose Strips. These totaled 62 million strips that had been distributed in the U.S., Canada, Chile, Peru, Argentina, Dominican Republic, Jamaica, United Kingdom, Belgium, Finland Congo and Saudi Arabia. In contrast to the Abbott strips, Nova Max strips resulted in false high glucose measurements.
Here is a list of the effected test strip lot numbers.
The company has requested that those with the affected strips, call 800-682-7390 to request replacement of the recalled item. Alberto Gutierrez, director of the FDA’s Center for Devices and Radiological Health said that “It is important that patients using these test strips discontinue their use immediately”.
Incorrect blood glucose readings are not limited to the glucose strips. Last Spring, Abbott’s FreeStyle InsuLinx Blood Glucose Meter, experienced a software glitch that resulted in erroneous low glucose readings being displayed and saved. Such false readings have the potential of delaying treatment for hyperglycemia and may have serious adverse health consequences.
Recommendations When Testing Blood Glucose at Home
- FDA advises that glucose testing should not be interrupted, even if only defective test strips are available.
- When opening a new vial of test strips, a sample control test strip should be used to verify the quality of the new strips. If the resulting readings are not within the suggested range, the strips should not be used.
- If results are inconsistent with historic glucose readings for the individual, then the test should be repeated using strips from another vial.
- If results remain inconsistent with historic glucose readings after being repeated, contact should be made with the healthcare provider.
- Regardless of the consistency of test results, if the individual feels the results are not accurate or they do not feel well, then contact should be made with the healthcare provider.
- The individual should make no adjustment in their diabetes management based solely on the strip results without input from their healthcare provider.
With these recent reports of inaccurate glucose readings due to glucose strips or software issues, a brief review symptoms that result from low and high sugar may be useful.
Symptoms of Hyperglycemia (High blood glucose)
- Feeling Excessively Thirsty
- Blurred Vision
- Excessive Urination
- Nausea, Vomiting or Stomach Pain
- Feeling Weak
Symptoms of Hypoglycemia (Low blood glucose)
- Sweating Excessively
- Feeling Hungry
- Feeling Weak
- Feeling Confused
Despite these recent recalls of home glucose testing supplies, there is no doubt that testing glucose levels at home is of major help to patients and providers in maintaining blood glucose levels within the proper range for longer periods of time. But we can’t forget, when the consequences are so great, that equipment can malfunction and errors occur in the manufacturing of supplies.
- Jacob J Klausner