OECDReferencia EN/AU/PS1101077
All MiniMed 640G, 670G, 700, 770G, and 780G Insulin Pumps
Información oficial organizada para facilitar su consulta. La publicación de la fuente conserva la autoridad.
Identificación
Identificación del producto
- Producto
- All MiniMed 640G, 670G, 700, 770G, and 780G Insulin Pumps
Información oficial
Riesgo y medidas
- Riesgo o peligro
- The gold battery cap contact may fall off when the user is charging the battery. If the contact falls off, the 'Insert battery' alarm will not clear automatically when the user inserts a new AA battery as the circuit is not complete. This will result in the alarm escalating to a siren and then the pump will shut down and will not power up. If insulin delivery is suspended, this may lead to major hyperglycemia which can result in serious health complications. In severe cases of hyperglycemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional.
- Recomendaciones
- Medtronic will contact affected users in writing to advise them of the issue. Consumers are advised to follow the interim actions outlined in the customer letter and to have an alternate means of insulin therapy available. For more details see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00725-1 For further information, please contact Medtronic Technical Support by phone on 1800 777 808.
Información oficial
Operadores económicos
- Fabricante
- Medtronic Australasia Pty Ltd
Territorio
Geografía
- Distribución
- Retirada en Australia
- País de retirada
- Australia
Procedencia y contexto
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