Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines & Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Medtronic MiniMed 600 and 700 series insulin pump battery cap [MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752); MiniMed 670G Insulin Pump (MMT-1761, MMT-1762, MMT-1781, MMT-1782); MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860), MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862); MiniMed 770G Insulin Pump (MMT-1881, MMT-1882, MMT-1891, MMT-1892); MiniMed 780G Insulin Pump (MMT, 1885, MMT-1886, MMT-1895, MMT-1896)] [HKMD No. (for MiniMed 640G Insulin Pump only): 170311].
According to the MHRA, the manufacturer is sending a letter to all pump users with a MiniMed 600 series and/or MiniMed 700 series that direct them to check during their battery replacement whether their battery cap and metal contact are damaged. The letter advises patients if the metal contact becomes loose or falls off from the battery cap, it can result in an incomplete battery connection, leading to no power source to the pump. When the pump detects no power source, an “Insert battery” alarm will occur, and insulin delivery will immediately stop. After 10 minutes, the alarm sound may increase to a siren, and the pump will turn off. If the pump stops delivery of insulin due to power loss, this could lead to varying degrees of high blood sugar, including Diabetic Ketoacidosis (DKA).
For further information, please visit https://mhra-gov.filecamp.com/s/EjhPPwNEC5Bfltj4/d
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 May 2022