Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LifeScan Inc A Jonhson 60 Jonhson Co.

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
    235
  • Date
    2000-12-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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