Recall Z-1771-2021 · OZP Automated Insulin Dosing Device System, Single Hormonal Control

Medtronic Minimed

MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE SF MG; PUMP MMT-1884XC 780G V6.5 CLIN US MG; PUMP MMT-1885XC 780G V6.5 CLIN MM; PUMP MMT-1886XC 780G V6.5 CLIN MG; PUMP MMT-1885L MM780G 6.5V BLE MMOL; PUMP MMT-1886L MM780G 6.5W BLE MG; KIT MMT-1896ES MM780G V6.5W MG; KIT M

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	O.U.S. Distibution only = 15,682 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.