{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-29", "results": { "skip": 0, "limit": 1, "total": 24700 } }, "results": [ { "manufacturer_contact_zip_ext": "-386", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "JUNCOS", "manufacturer_contact_address_1": "CEIBA NORTE IND. PARK #50 ROAD", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2032227-2026-184511", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260603", "manufacturer_address_2": "", "pma_pmn_number": "P160017", "date_of_event": "20260517", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "00777", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "PATEL", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "00777-3869", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260603", "manufacturer_contact_f_name": "KEYA", "device_date_of_manufacturer": "20240618", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1433255", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260603", "brand_name": "MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL", "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_address_2": "", "manufacturer_d_city": "JUNCOS", "manufacturer_d_state": "", "manufacturer_d_zip_code": "00777", "manufacturer_d_zip_code_ext": "-386", "manufacturer_d_country": "*", "manufacturer_d_postal_code": "00777-3869", "device_operator": "LAY USER/PATIENT", "model_number": "MMT-1884", "catalog_number": "MMT-1884", "lot_number": "NG3806591H", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OZP", "device_age_text": "", "device_evaluated_by_manufacturer": "*", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Automated Insulin Dosing Device System, Single Hormonal Control", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Obstruction of Flow" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "*", "date_changed": "20260615", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "-386", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "40 YR", "patient_sex": "Male", "patient_weight": "99 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hyperglycemia" ] } ], "distributor_city": "", "date_report": "20260602", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "*", "manufacturer_contact_city": "JUNCOS", "mdr_report_key": "25369305", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260520", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "00777", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC PUERTO RICO OPERATIONS CO.", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "404503068", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "404503069", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED TO MINIMED THAT THE CUSTOMER EXPERIENCED AN INFUSION FLOW BLOCKED ALARM AND HYPERGLYCEMIA THAT PERSISTED FOR MORE THAN FOUR (4) HOURS, WHICH WAS TREATED WITH MANUAL INJECTION/INSULIN PEN. THE BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 350 MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-397A, MMT-1884 AND MMT-332A. TROUBLESHOOTING WAS PERFORMED FOR INFUSION FLOW BLOCKED ALARM AND IT WAS A PAST EVENT WHICH WAS NOT RESOLVED. THE CUSTOMER CONFIRMED HAVING A PLUNGER AVAILABLE. THE CUSTOMER WAS ADVISED TO DISCONNECT THE SET AND RESERVOIR AND, PUSH INSULIN SLOWLY THROUGH THE TUBING USING THE PLUNGER, AND INSULIN WAS OBSERVED EXITING THE TUBING. THE CUSTOMER WAS THEN ADVISED TO REWIND THE PUMP, REINSERT THE RESERVOIR, AND RUN THE FILL TUBING PROCESS UNTIL AT LEAST 5 UNITS OF INSULIN WERE OBSERVED EXITING OR THE PUMP ALARMED. INSULIN WAS OBSERVED EXITING THE TUBING AND THE PUMP SUCCESSFULLY PASSED THE 5-UNIT FILL CANNULA TEST. TROUBLESHOOTING WAS PERFORMED FOR HYPERGLYCEMIA EVENT AND, IT WAS CONFIRMED THAT THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT, AND THE AUTO MODE/SMARTGUARD FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A, MMT-1884 AND MMT-332A." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CEIBA NORTE IND. PARK #50 ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "00777-3869", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }