Recall Z-1772-2021 ยท OZP Automated Insulin Dosing Device System, Single Hormonal Control
Medtronic Minimed
MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN; PUMP MMT-1740KX 670G V6.3 CLIN 020 MG; PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR; PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG; PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER; PUMP MMT-1741KX 670G V6.3 CLIN 020 MG; PUMP MMT-1741KXS 670G V6.3 SF MG CLIN IS; PUMP MMT-1741KXS 670G V6.3 CLIN 020 MG; PUMP MMT-1742KX 670G V6.1 MM CLIN; PUMP MMT
| Date | Mar 15, 2021 |
| Status | Open, Classified |
| Reason | Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery. |
| Root cause | Software design |
| Action | On 03/15/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via regionally approved methods (e.g. email, registered mail, courier, hand delivery) informing customers that their insulin pump with software version 6.5 that could present pump errors after delivering a large bolus under certain conditions. These errors may occur if All the following conditions are met: 1-The bolus delivery speed is programmed to Quick in the pump settings (default is Standard). 2-The SmartGuard" feature is in use. 3-The pump needs to be on the bolus delivery screen when an auto corr |
| Quantity | U.S. Investigational Clinical Study = 1,266 devices |
| Distribution | U.S.(Clinical): AR, CA, CO, CT, FL, GA, ID, MI, MN, TN, TX, and WA O.U.S.: Austria, Bahrain, Belgium, Canary Islands, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Liechtenstein, Luxembourg, Malta, Martinique, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.