{ "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": "2026-07-28", "results": { "skip": 0, "limit": 1, "total": 1 } }, "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": "2032227-2026-198077", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260630", "manufacturer_address_2": "", "pma_pmn_number": "EXEMPT", "date_of_event": "20260622", "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": [ "Foreign", "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "00777-3869", "manufacturer_g1_state": "", "reporter_country_code": "RS", "manufacturer_contact_area_code": "", "date_added": "20260630", "manufacturer_contact_f_name": "KEYA", "device_date_of_manufacturer": "20240510", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "316823", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260630", "brand_name": "MINIMED 720G OUS BLE CONNECT 3.0 MMOL/L", "generic_name": "PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR", "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-1809", "catalog_number": "MMT-1809", "lot_number": "NG3773627H", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OYC", "device_age_text": "", "device_evaluated_by_manufacturer": "*", "combination_product_flag": "N", "udi_di": "000000763000541330", "udi_public": "(01)000000763000541330", "openfda": { "device_name": "Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Power Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "*", "date_changed": "20260701", "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": "20260630", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260629", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "*", "manufacturer_contact_city": "JUNCOS", "mdr_report_key": "25662218", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260622", "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": "406155486", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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": "406155487", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED TO MINIMED THAT THE CUSTOMER RECEIVED CRITICAL PUMP ERROR (OPEN BOOK IMAGE). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1809. TROUBLESHOOTING WAS PERFORMED. CUSTOMER USING THE CORRECT BATTERY CAP FOR THE PUMP. THE PUMP DID NOT SHOW ANY SIGNS OF DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1809 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED." } ], "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": "" } ] }