OECDReferencia EN/AU/PS1095892
MiniMed 640G and 670G Insulin Pumps
Información oficial organizada para facilitar su consulta. La publicación de la fuente conserva la autoridad.
Identificación
Identificación del producto
- Producto
- MiniMed 640G and 670G Insulin Pumps
Información oficial
Riesgo y medidas
- Riesgo o peligro
- If the pump retainer ring breaks, the reservoir may become loose and may not lock into the pump. If the retainer ring is damaged, loose or missing, this may lead to under delivery of insulin, which may cause hyperglycemia. If a user inserts the reservoir back in while the infusion set is still connected to the body, there may be a rapid infusion of insulin, which may cause hypoglycemia or death.
- Recomendaciones
- If the reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, consumers should immediately discontinue using the insulin pump and revert to a back-up plan with the healthcare provider’s recommendations. Do not insert the reservoir back into the pump while connected. If the reservoir properly locks in place with the retainer ring and the retainer ring is not loose, damaged, or broken, consumers may continue to use their pump until they receive a replacement pump. In the interim, consumers should inspect the retainer ring on the pump and examine the retainer ring for damage every time the infusion set is changed. The supplier will contact affected consumers and direct them to visit https://info.medtronicdiabetes.com/Clear_Retainer_Ring, call the Medtronic Global Help Line on 1800 777 808, or complete and return the Confirmation Form to receive a replacement pump at no charge.
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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