Events

Safety Alert for MediSense Optium / Precision Blood Glucose Test Tapes Monitoring System. Parts No. 99134-15; Lots # 50111, 50113, 50123 Valid until September 30, 2002.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratories MediSense Products; MediSense Contract Mfg.

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
    394
  • Date
    2002-02-25
  • 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
    The calibrator, the white bar, had incorrect programming for glucose tapes for the tests above. if the affected calibrator is used, the medisense optium / pecision extra blood glucose monitor will prompt the message "cal error", followed by a "313" or "316" error code, and the monitor will not calibrate correctly. the distributor declares that the problem does not influence the customer's safety outcome, and that they are taking appropriate corrective and preventive actions to prevent replication. the distributor initiated a correction by letter dated october 2, 2001.
  • Action
    Verify that you received the letter dated October 2, 2001, return form, sample letter Abbott MediSense. The distributor declares that it is important to calibrate the monitor with each new test cassette box. Identify and isolate any affected product in your inventory. Use the response form to confirm your current inventory, and return the form to your local Abbott Laboratories representative. Upon receipt of the form, you will receive credit for your inventory and MediSense Accounts, Sales and Services representatives will contact you to arrange for the return of the affected product. Notify any customer who has purchased affected lots with this fix; the Abbott MediSense sample letter can be used for this. For more information, contact your local Abbott MediSense representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

MediSense Optium / Precision Blood Glucose Test Tapes Monitoring System. Parts No. 99134-15; Lots...

Manufacturer

Abbott Laboratories MediSense Products; MediSense Contract Mfg
  • Source
    ANVSANVISA