Аналіз інформації за період 01.08.2016 – 31.08.2016, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

Опубліковано 02.09.2016 о 00:00




·         Accu-Chek® Insight insulin pump system manufactured by Roche Diabetes Care with NovoRapid® PumpCart® cartridges – risk of hyperglycaemia

Cartridges inserted incorrectly can leak insulin into the cartridge compartment, resulting in an under-delivery of insulin, which may lead to rapid deterioration of health, diabetic ketoacidosis or death.

Alert type: Medical device alert Issued: 15 August 2016

·         Home use blood glucose monitoring system: TRUEresult and TRUEtrack blood glucose test strips – risk of false low blood glucose results.

Manufactured by Nipro Diagnostics, certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia. This Alert refers to different blood glucose test strips to those covered by MDA/2016/009R.

Alert type: Medical device alert Issued: 10 August 2016

·         SerenoCem Granules – risk of bone reabsorbtion around granules

Manufactured by Corinthian Surgical Ltd – risk of bone reabsorbtion around granules implanted in the middle ear (MDA/2016/013)

Alert type: Medical device alert Issued: 4 August 2016

·         VentStar Oxylog3000F (P) 190 Disposable paediatric ventilation circuit for Oxylog 3000 and Oxylog 3000 plus ventilators – risk of rebreathing exhaled gases

Manufactured by Draeger Medical – Return ventilation circuits manufactured up to and including March 2016 as they may leak at the check valve.

Alert type: Medical device alert Issued: 3 August 2016

·         Babytherm® 8004/8010 Infant Warmer, manufactured by Drägerwerk AG & Co – risk of fire

In skin-temperature control mode, if the temperature sensor is not connected or detaches from the patient, the heating element may overheat causing particles to detach; potentially leading to fire and patient harm or death.

Alert type: Medical device alert Issued: 2 August 2016


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