FreeStyle and FreeStyle Flash Blood Glucose Meters including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM) have been recalled due to erroneously low blood glucose results.
FreeStyle and FreeStyle Flash Blood Glucose Meters measure sugar (glucose) levels in blood samples of people with diabetes. The meters are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. Additionally, the OmniPod PDM system contains an integrated FreeStyle meter.
The manufacturer, Abbott Diabetes Care, has identified that certain meters have the potential to produce erroneously low blood glucose results when used in conjunction with certain Free Style test strips. This issue occurs with FreeStyle, FreeStyle Flash Blood Glucose meters and the FreeStyle blood glucose meter built into the OmniPod Insulin Management System.
Abbott Diabetes Care is requesting users of the FreeStyle and FreeStyle Flash Blood Glucose Meters to discontinue use of these meters and to call Abbott for a new unaffected meter. If the only meter available is a FreeStyle or FreeStyle Flash Blood Glucose Meter, do not stop testing blood glucose.
Users of the FreeStyle Blood Glucose Meter built into the OmniPod PDM are requested to discontinue use of affected test strips and to call Abbott for replacement unaffected test strips. Users should continue using your OmniPod Insulin Management System (OmniPod) to deliver your insulin therapy. While waiting for your replacement strips to arrive, use the FreeStyle Freedom blood glucose meter that shipped with the welcome pack. FreeStyle test strips when used with the FreeStyle Freedom blood glucose meter will produce accurate blood glucose results. Users who would like to continue using the OmniPod system to recommend dosing should follow the OmniPod Insulin Management System instructions for manually entering blood glucose readings.
Users of FreeStyle and FreeStyle Flash Blood Glucose Meters and the FreeStyle Blood Glucose Meter built into the OmniPod PDM Users should use control solutions to check the performance of the test strips and meter until replacement test strips are received. If any reading from a strip appears lower than expected or does not seem to match the way the user is feeling, the user should contact a health care provider immediately. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). Symptoms of high blood sugar may include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, May 2014 Report (published May 7, 2014): Diagnosis and Treatment of Diabetes: Malpractice and Liability Issues