Recall Z-0516-2021 ยท OZP Automated Insulin Dosing Device System, Single Hormonal Control
Medtronic Inc.
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns an
| Date | Apr 30, 2020 |
| Status | Open, Classified |
| Reason | Missing solder battery connection, which could interrupt power of insulin pump. |
| Root cause | Nonconforming Material/Component |
| Action | On April 30, 2020, the firm mailed a "Urgent Medical Device Recall" letter to patients. The firm also sent a letter to Health Care Professionals, (HCP) "Urgent Medical Device Recall" that they read this notice and confirm receipt that the customer read and understood the instructions provided in this letter. The letter notified customers that the insulin pumps had an issue on the battery connection that did not meet firm's quality specifications. If power is interrupted on a patients insulin pump, then insulin is suspended, which may lead to hyperglycemia (high blood sugar). There have been no |
| Quantity | 391 |
| Distribution | Worldwide distribution - U.S. Nationwide Distribution in the state of MD and the countries of Canada, Netherlands, Norway. ***Model 630G distributed in Canada and Model 670G distributed in US ***MODEL640G Distributed OUS ONLY*** OUS: Australia, Canada, Netherlands and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.