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

Safety alert

394

2002-02-25

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

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.

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.