Recall Z-0855-2022— Medtronic MiniMed
Class II · Ongoing
Class II FDA medical device recall by Medtronic MiniMed, initiated 2022-01-27. FDA's recall record names no specific 510(k) clearance for this event. Product: MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS Only): MMT-1711, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G (OUS Only): MMT-1809, MMT-1810, MMT-1859, MMT-1860; MiniMed 740G (OUS Only): MMT-1811, MMT-1812, MMT-1861, MMT-1862; MiniMed 780G (OUS Only): MMT-1884, MMT-1885, MMT-1886, MMT-1895, MMT-1896 The MiniMed" 630G System with SmartGuard is intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons sixteen years of age and older.. Reason: New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different..
- Recalling firm
- Medtronic MiniMed
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-27
- Firm location
- Northridge, CA, United States
Product description
MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS Only): MMT-1711, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G (OUS Only): MMT-1809, MMT-1810, MMT-1859, MMT-1860; MiniMed 740G (OUS Only): MMT-1811, MMT-1812, MMT-1861, MMT-1862; MiniMed 780G (OUS Only): MMT-1884, MMT-1885, MMT-1886, MMT-1895, MMT-1896 The MiniMed" 630G System with SmartGuard is intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons sixteen years of age and older.
Reason for recall
New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.
Data sourced from openFDA. This site is unofficial and independent of the FDA.