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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Medtronic Puerto Rico Operations Co. MiniMed 780G US System BLE Connect 3.0 mg/dL; Alternate Controller Enabled Insulin Infusion Pump

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Medtronic Puerto Rico Operations Co. MiniMed 780G US System BLE Connect 3.0 mg/dL; Alternate Controller Enabled Insulin Infusion Pump Back to Search Results
Model Number MMT-1884
Medical Device Problem Code Power Problem (3010)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/01/2026
Type of Reportable Event Malfunction
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Brand Name
MiniMed 780G US System BLE Connect 3.0 mg/dL
Common Device Name
Alternate Controller Enabled Insulin Infusion Pump
Manufacturer (Section D)
Medtronic Puerto Rico Operations Co.
ceiba norte ind. park #50 road
juncos 00777 -386
PR  00777-3869
Manufacturer (Section G)
Medtronic Puerto Rico Operations Co.
ceiba norte ind. park #50 road
juncos 00777 -386
PR   00777-3869
Manufacturer Contact
keya patel
ceiba norte ind. park #50 road
juncos 00777--386
PR   00777-3869
MDR Report Key50204214
Report Number2032227-2026-220290
Device Sequence Number13105253
Product Code QFG
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P160017
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 08/31/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model NumberMMT-1884
Device Catalogue NumberMMT-1884
Device Lot NumberNG3750830H
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/17/2026
Is the Reporter a Health Professional? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2026
Supplement Date Received by Manufacturer08/18/2026
Initial Report FDA Received Date08/31/2026
Supplement Report FDA Received Date08/31/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured04/05/2024
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
Patient Age62 YR
Patient SexMale
Patient Weight165 LB
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