PRECISION XCEED PRO - Registration 80146501647 - Serial Numbers as listed in the appendix. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The Abbott Diabetes Care Risk Assessment (ADC RE1058-2012 Rev02) was conducted to verify the risk associated with the G3cH test strips being producing out of range results when using the high and low control solutions, and higher% CV and DP results than those considered acceptable by consumers. Consequently, two failure modes were verified as part of the risk assessment. In failure mode 1, the blood glucose test strips were tested with low level control solution and fell out of the determined range, and therefore failed in quality control checks performed by healthcare institutions. If the multiple out-of-range results can not be resolved, and the institution has set parameters for the monitors to block in a situation as it stands, there is a potential failure to detect hypoglycemia or hyperglycemia resulting in a delay in treatment, or treatment in the absence of data from glucose. In Failure Mode 2, glucose tests were tested with control solution and may produce a higher CV than expected (low CV CV level> 10%), which may result in the consumer choosing not to use the test strips. The% CV values ​​are not parameterized by the ADC (No specification) nor included in the labeling, but there are internal expectations or limits that the client parameterizes for product performance. If the consumer chooses not to use the test strips, there is a potential risk of failure to detect hypoglycemia or hyperglycemia, resulting in a delay in treatment or treatment in the absence of glucose data. The resulting risk indices were "low" for both failure modes.