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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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(Medtronic) May lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). (MDA/2013/035)
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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 - 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 health e.g. hypoglycaemia or diabetic ketoacidosis.
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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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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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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 23 to 27 May 2022.
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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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Summary List of field safety notices (FSNs) from medical device manufacturers from 13 February - 17 February 2017
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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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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 18 to 22 November 2019.
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List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 February 2015.
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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 15 to 19 March 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 March 2016.
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A list of all medical device alerts that were archived in May 2015.
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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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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 12 to 16 September 2022
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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 22 to 26 June 2015.
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List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 January 2015.
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A list of all medical device alerts that were archived in October 2016.
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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 28 September to 2 October 2015.
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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 29 June to 3 July 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 (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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List of field safety notices (FSNs) from medical device manufacturers from 1 October to 5 October
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List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 February 2022.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 May 2017.
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List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 October 2021
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Summary List of field safety notices (FSNs) from medical device manufacturers from 5 - 9 September 2016
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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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A list of all medical device alerts that were archived in September 2015.
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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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Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.
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(Medtronic) diamorphine solution is incompatible with the implantable drug pump. (MDA/2003/035)
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(Medtronic) Risk of delays in the resumption of drug infusion and in logging of motor stall events after MRI scans. (MDA/2008/087)
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List of Field Safety Notices from15 to 19 April 2024.
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A list of all medical device alerts that were archived in December 2015.
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Regular safety information for healthcare professionals
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Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.