Events

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

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 Laboratories MediSense Products; MediSense Contract Mfg.

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
    394
  • Date
    2002-02-25
  • 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
    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