Alerte De Sécurité sur PRECISION XCEED PRO - Registration 80146501647 - Serial Numbers as listed in the appendix.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ABBOTT LABORATORIOS DO BRASIL.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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 or call 0800-703-0128.


  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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