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The MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump.…
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If patients are contacted directly by a manufacturer or other organisation to try using a different insulin therapy system they should first discuss this with their diabetes specialist to avoid risk of hyperglycaemia, hypoglycaemia or diabetic ketoacidosis.
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(Medtronic) May lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). (MDA/2013/035)
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Manufactured by Roche Diabetes Care - inadequately detailed handling instructions of the 'Key Lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of he…
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(Roche Diagnostics Ltd) Increased risk that the vibration alarm will not work as a result of a changed component. (MDA/2014/008)
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(Medtronic) Risk due to incorrect selection and delivery of bolus amount. (MDA/2014/019)
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Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
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(Novo Nordisk A/S) Patients who may have received the affected batches should be contacted and asked to check their supply – class 2 action within 48 hours. (EL (13)A/25)
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Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 May 2022.
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Novo Nordisk is recalling one batch as a precautionary measure due to the presence of particles in a small number of samples.
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List of field safety notices (FSNs) from medical device manufacturers from 31 January to 4 February 2022.
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A list of all medical device alerts that were archived in September 2015.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 13 February - 17 February 2017
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List of field safety notices for week 03 to 07 October 2022
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List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 December 2019.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 10 to 14 May 2021
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Following our latest review of medical device alerts, we have archived the ones listed below.
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A list of all medical device alerts that were archived in December 2015.
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List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 March 2015.
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List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 March 2021.
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List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 February 2015.
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A list of all medical device alerts that were archived in March 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 November 2019.
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Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK.
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A list of all medical device alerts that were archived in May 2015.
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Following our latest review of medical device alerts, we have archived the ones listed below.
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List of Field Safety Notices from 23 to 27 September 2024.
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List of Field Safety Notices from 29 April to 3 May 2024.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 September 2022
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List of Field Safety Notices from 12 to 16 August 2024.
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List of Field Safety Notices (FSNs) from 15 to 19 January 2024.
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A list of all medical device alerts that were archived in October 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 January 2019
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Summary of the latest safety advice for medicines and medical device users
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List of field safety notices (FSNs) from medical device manufacturers from 28 September to 2 October 2015.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 August 2022.
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List of field safety notices (FSNs) from medical device manufacturers from 21 October to 25 October
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List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 July 2015.
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List of field safety notices (FSNs) from medical device manufacturers from 29 June to 3 July 2015.
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List of Field Safety Notices from 13 to 17 November 2023.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 March 2020
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 April 2017
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Following our latest review of medical device alerts, we have archived the ones listed below.
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List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 January 2015.
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A list of all medical device alerts that were archived in July 2016.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 February 2020
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List of Field Safety Notices from 10 to 14 March 2025.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 30 October to 3 November 2017.
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List of field safety notices (FSNs) from medical device manufacturers from 1 October to 5 October