BEUDAMED
    FDA Recall Open, Classified

    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 MMT-1896WWA MM780G BLE MG ES; KIT MMT-1895WWA MM780G BLE MMOL AR; KIT MMT-1895WWA MM780G BLE MMOL CS; KIT MMT-1895WWA MM780G BLE MMOL DA; KIT MMT-1895WWA MM780G BLE MMOL DE; KIT MMT-1895WWA MM780G BLE MMOL EN; KIT MMT-1895WWA MM780G BLE MMOL FI; KIT MMT-1895WWA MM780G BLE MMOL FR; KIT MMT-1895WWA MM780G BLE MMOL IT; KIT MMT-1895WWA MM780G BLE MMOL NL; KIT MMT-1895WWA MM780G BLE MMOL NO; KIT MMT-1895WWA MM780G BLE MMOL SL; KIT MMT-1895WWA MM780G BLE MMOL SV; KIT MMT-1895WWA MM780G BLE MMOL HU; KIT MMT-1896WWA MM780G BLE MG AR; KIT MMT-1896WWA MM780G BLE MG DE; KIT MMT-1896WWA MM780G BLE MG EL; KIT MMT-1896WWA MM780G BLE MG HE; KIT MMT-1896WWA MM780G BLE MG IT; KIT MMT-1896WWA MM780G BLE MG PL; KIT MMT-1896WWA MM780G BLE MG RO; KIT MMT-1896WWA MM780G BLE MG TR; KIT MMT-1896WWA MM780G BLE MG NL; KIT MMT-1896WWA MM780G BLE MG FR; KIT MMT-1896WWA MM780G BLE MG ES;

    Recall: Z-1771-2021 · Initiated March 15, 2021

    Recall

    Recall Number
    Z-1771-2021
    Event Number
    87735
    Firm
    Medtronic Minimed
    FEI Number
    3003166194
    Product Code
    OZP
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 15, 2021
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    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 MMT-1896WWA MM780G BLE MG ES; KIT MMT-1895WWA MM780G BLE MMOL AR; KIT MMT-1895WWA MM780G BLE MMOL CS; KIT MMT-1895WWA MM780G BLE MMOL DA; KIT MMT-1895WWA MM780G BLE MMOL DE; KIT MMT-1895WWA MM780G BLE MMOL EN; KIT MMT-1895WWA MM780G BLE MMOL FI; KIT MMT-1895WWA MM780G BLE MMOL FR; KIT MMT-1895WWA MM780G BLE MMOL IT; KIT MMT-1895WWA MM780G BLE MMOL NL; KIT MMT-1895WWA MM780G BLE MMOL NO; KIT MMT-1895WWA MM780G BLE MMOL SL; KIT MMT-1895WWA MM780G BLE MMOL SV; KIT MMT-1895WWA MM780G BLE MMOL HU; KIT MMT-1896WWA MM780G BLE MG AR; KIT MMT-1896WWA MM780G BLE MG DE; KIT MMT-1896WWA MM780G BLE MG EL; KIT MMT-1896WWA MM780G BLE MG HE; KIT MMT-1896WWA MM780G BLE MG IT; KIT MMT-1896WWA MM780G BLE MG PL; KIT MMT-1896WWA MM780G BLE MG RO; KIT MMT-1896WWA MM780G BLE MG TR; KIT MMT-1896WWA MM780G BLE MG NL; KIT MMT-1896WWA MM780G BLE MG FR; KIT MMT-1896WWA MM780G BLE MG ES;

    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.

    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 correction bolus is triggered. Auto corrections are triggered when sensor glucose (SG) is running high and Active Insulin is low. 4-The bolus amount programmed to be delivered is greater than 17.1U. Note: This can be a single bolus greater than 17.1U or a combination of boluses totaling greater than 17.1U. If all the above conditions are met, within 2 minutes of bolus delivery completion, the pump initiates Pump error 53, followed by Pump error 23 alarm. Upon clearing the pump errors, the pump resets and indicates Active Insulin has been cleared. The pump then guides the user to resume operation in Manual Mode. The SmartGuard" status screen indicates the warm-up period has started. After approximately 5 hours, the SmartGuard" feature will be available. Since Active Insulin will display 0.0 units in the pump after experiencing the pump errors above, 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, which may result in low blood sugar (hypoglycemia) or severe hypoglycemia. In rare cases, severe hypoglycemia, if left untreated, may lead to a life-threatening situation. As of January 21, 2021, Medtronic has received no reports of serious patient harm or serious injury related to this issue. Customers are instructed to: If their pump screen indicates that Active Insulin has cleare

    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, Netherlands, New Caledonia, Norway, Poland, Qatar, Reunion, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom

    Quantity

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