Recall Z-0855-2022 ยท OZP Automated Insulin Dosing Device System, Single Hormonal Control
Medtronic MiniMed
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
| Date | Jan 27, 2022 |
| Status | Open, Classified |
| 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 |
| Root 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.