Events

Alerte De Sécurité sur SureStep blood glucose monitoring systems. Catalog No. 010-341; Series No.s .: L6000 XX XXXXX to L7205 XX XXXXX, L7206 GA 00001 to L7206 GA 01128

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 LifeScan Inc A Jonhson 60 Jonhson Co.

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
    235
  • Date
    2000-12-15
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    Removal of the monitors mentioned because of a message error1 that appears in place of a reading saying "high" when a patient's blood glucose was> = 500mg / dl. on friday, december 15, 2000, lifescan pleaded guilty to the indictment in federal court for improper identification of a medical device, refusing to provide proper fda notification, and reporting false and misleading fda findings to the fda. connection with the investigation of the mentioned problems with the surecan monitor. the author states that lifescan knew about the two defects in the monitors and did not disclose the problems to customers and the fda. lifescan was forced to pay $ 60 million in fines. jonhson & jonhson stated that no lifescan employee was involved in a deliberate wrongdoing, however, they admitted that the product label was defective and that the company did not notify the fda and was very slow in providing a solution to the problem. the author reports that the guilty plea has also determined a civil claim settlement where the us government received $ 30.6 million in restitution of medical care funds used to purchase surescan monitors. another class action lawsuit filed on behalf of users of surescan monitors is still pending.
  • Action
    Make sure that you have been contacted by LifeScan. Lifescan states that the problems were corrected in 1997 and 1998, with the affected meters having been replaced, free of charge, by the company. ECRI states that it currently classifies SureStep's glucose monitor as an acceptable device and has no evidence to suggest that this rating should be changed. If you are using a Sure Step glucose monitor and have questions, please contact your local representative or directly with LifeScan at 1 (408) 946-6070 in the USA. If you observe any measurement that is incorrect or inconsistent with the clinic, notify the event to ANVISA's Tecnovigilância by e-mail tecnovigilância@anvisa.gov.br or by telephone / fax 0xx-61-448-1257.

Device

SureStep blood glucose monitoring systems. Catalog No. 010-341; Series No.s .: L6000 XX XXXXX to ...

Manufacturer

LifeScan Inc A Jonhson 60 Jonhson Co
  • Source
    ANVSANVISA