Events

Safety Alert for PRECISION XCEED PRO - Registration 80146501647 - Serial Numbers as listed in the appendix.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATORIOS DO BRASIL.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1235
  • Date
    2013-03-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Complaints have been raised by point of care (poc) customers worldwide reporting that the g3ch blood glucose test strips are producing readings out of their ranges when using high and low control solution. the accuracy measures of cv% and dp (standard deviation) were also reported as exceeding the considerable ones as acceptable by customers. in the complaints received, the number of results obtained out of range in quality control checks were reported as increasing, requiring that these checks be repeated multiple times.
  • Action
    Abbott Diabetes Care has a firmware update for the Xceed Pro Precision Monitor that addresses this issue. If you have had this problem and would like to schedule an update, please contact the company at supportadcbrasil@abbott.com or call 0800-703-0128.

Device

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

Manufacturer

ABBOTT LABORATORIOS DO BRASIL
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA