Device adverse event reports (MAUDE)

MiniMed 780G OUS System BLE Connect 3.0 mmol/L · AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Medtronic Puerto Rico Operations Co. · Circuit Failure

MalfunctionInitial submissionMDR 50941442
Manufacturer contact zip ext
-386
Manufacturer link flag
Y
Manufacturer g1 city
Juncos
Manufacturer contact address 1
Ceiba Norte Ind. Park #50 Road
Event type
Malfunction
Report number
2032227-2026-246722
Product problem flag
Y
Date received
20260930
PMA pmn number
Exempt
Date of event
20251219
Reprocessed and reused flag
N
Manufacturer contact zip code
00777
Reporter occupation code
003
Noe summarized
1
Manufacturer contact l name
Patel
Manufacturer g1 postal code
00777-3869
Reporter country code
FI
Date added
20260930
Manufacturer contact f name
Keya
Device date of manufacturer
20241022
Mfr report type
Thirty-Day
Manufacturer contact country
PR
Date changed
20260930
Health professional
N
Summary report flag
N
Manufacturer g1 zip code ext
-386
Date report
20260929
Initial report to FDA
No
Manufacturer g1 country
PR
Manufacturer contact city
Juncos
MDR report key
50941442
Date manufacturer received
20251219
Report source code
Manufacturer report
Manufacturer g1 zip code
00777
Manufacturer g1 name
Medtronic Puerto Rico Operations Co.
Adverse event flag
N
Single use flag
N
Manufacturer g1 address 1
Ceiba Norte Ind. Park #50 Road
Manufacturer contact postal code
00777-3869
Type of report
Initial submission
Source type
Foreign, Consumer
Device
  1. Device sequence number
    319553
    Date received
    20260930
    Brand name
    MiniMed 780G OUS System BLE Connect 3.0 mmol/L
    Generic name
    AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
    Manufacturer d name
    Medtronic Puerto Rico Operations Co.
    Manufacturer d address 1
    Ceiba Norte Ind. Park #50 Road
    Manufacturer d city
    Juncos
    Manufacturer d zip code
    00777
    Manufacturer d zip code ext
    -386
    Manufacturer d country
    PR
    Manufacturer d postal code
    00777-3869
    Device operator
    LAY USER/PATIENT
    Model number
    MMT-1885
    Catalog number
    MMT-1885
    Lot number
    NG3913786H
    Device availability
    No
    Device report product code
    OZP
    Combination product flag
    N
    UDI di
    000076300063922801
    UDI public
    (01)000076300063922801(17)271022
    Harmonized identifiers (openFDA)
    Device name
    Automated Insulin Dosing Device System, Single Hormonal Control
    Medical specialty description
    Unknown
    Device class
    3
Product problems
Circuit Failure
Patient
  1. Patient sequence number
    1
    Patient problems
    No Clinical Signs, Symptoms or Conditions
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.