Class 2 Device Recall MiniMed 620G, 630G, 640G, 670G, 700, 720G, 740G, 770G, 780G Insulin Infusion Pumps

• Date Initiated by Firm: January 27, 2022
• Create Date: March 31, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0855-2022
• Recall Event ID: 89653
• PMA Number: P160017 P150001
• Product Classification: Automated insulin dosing device system, single hormonal control - Product Code OZP
• 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.
• Code Information: Insulin pumps distributed in the last 6 months. All devices (US) serial numbers ranging from NG2056884H TO NG2891033H and (OUS) serial numbers ranging from NG1921788H TO NG2883091
• Recalling Firm/ Manufacturer: Medtronic MiniMed; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: 818-576-4700
• Manufacturer 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.
• FDA Determined Cause: Labeling design
• Action: On 01/27/22, correction notices were sent to patients, healthcare providers, and distributors who were asked to do the following: 1) Consult with your healthcare professional to determine the settings before using the pump. 2) Existing Users with replacement or upgrade devices should: - Verify current basal rate pump settings. See user guide Viewing your basal information section. Settings can be saved on CareLink or written down on a paper. - If the basal rate settings are not present on your pump, please take all the following actions: Locate pump settings and consult with your healthcare professional to verify the most recent settings. If previous settings were uploaded to CareLink within 90 days, log into CareLink Personal, navigate to Reports , then Select custom range to choose a week that had the previous pump s upload, select DEVICE SETTINGS SNAPSHOT , and select Generate reports . Settings should have a non-zero basal rate. Refer to the user guide for detailed pump programming instructions. When programming basal rate settings, scroll down to select Done and then select Save on the next screen to activate the basal rate settings. Settings successfully saved when the message Changes saved . Customers requiring assistance can call Technical Support at 1-800-646-4633, option 1. Complete/return the confirmation form. Distributors were provided with the Patient and Healthcare Provider letters, and asked to 1) notify their customers and provide status updates to the recalling firm, or 2) provide the recalling firm with their customer list so the recalling firm can provide the correction information to customers directly. MiniMed Pump Basal Setting Programming Support [medtronicdiabetes.com/basal-setting-support]; CareLink Personal [carelink.minimed.com]; User Guides/Manuals, [medtronicdiabetes.com/630g-user-guide], [medtronicdiabetes.com/670g-user-guide], [medtronicdiabetes.com/770g-user-guide].
• Quantity in Commerce: 175,801
• Distribution: US: OH, UT, IL, NY, FL, LA, NE, NV, CA, VA, TX, DE, KS, MS, MI, AL, OK, AZ, SC, IN, AR, PA, WV, MA, RI, NJ, CO, TN, KY, GA, WI, MN, NM, MD, IA, NC, WY, MO, WA, OR, CT, ND, ME, VT, ID, SD, AK, MT, NH, DC, HI, PR, VI OUS: Australia, Japan, Korea, New Zealand, Taiwan, Viet Nam
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = OZP