{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 1926622 } }, "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": "81854648", "event_type": "Malfunction", "report_number": "2032227-2020-110239", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200421", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "00777", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "8185464805", "noe_summarized": "1", "manufacturer_contact_l_name": "DE GRAAFF", "source_type": [ "Other", "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "00777-3869", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "818", "date_added": "20200427", "manufacturer_contact_f_name": "GERWIN", "device_date_of_manufacturer": "20190710", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "466516", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "PUMP MMT-1780KPK 670G PATHWAY BLACK MG", "generic_name": "ARTIFICIAL PANCREAS 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-1780KPK", "catalog_number": "MMT-1780KPK", "lot_number": "HG3KTAG", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200424", "device_report_product_code": "OZP", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00763000190460", "udi_public": "(01)00763000190460", "openfda": { "registration_number": [ "2032227" ], "fei_number": [ "3003166194" ], "device_name": "Automated Insulin Dosing Device System, Single Hormonal Control", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Circuit Failure", "Display or Visual Feedback Problem", "Circuit Failure", "Display or Visual Feedback Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/02/2020;01/26/2023", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "-386", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "8185", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "11 YR", "patient_sex": "Female", "patient_weight": "34 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Clinical Signs, Symptoms or Conditions", "No Consequences Or Impact To Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230130", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "JUNCOS", "mdr_report_key": "10000143", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200421", "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": "193593670", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE POWER UP PROPERLY AFTER BATTERY INSTALLATION. DEVICE PASSED SELF TEST AND DISPLACEMENT TEST. POWER CONNECTOR PLUG IN AND LOCKED IN PLACE PROPERLY. DEVICE SHOWS NO DAMAGE ON LCD CONTROLLER OR LCD GLASS HOWEVER, PUMP ERROR 63 ALARM (VARIABLE 12) CONFIRMED IN THE DEVICE HISTORY DUE TO A SOFTWARE ERROR." }, { "mdr_text_key": "334544930", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. THE INFORMATION THAT PROVIDED WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN INCLUDED WITH THIS REPORT. THE INFORMATION RELATED TO MEDICAL DEVICE PROBLEM CODE HAS BEEN UPDATED AND PROVIDED IN THIS REPORT. THE INFORMATION RELATED TO OCCUPATION HAS BEEN UPDATED AND PROVIDED IN THIS REPORT." }, { "mdr_text_key": "334544931", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE DEVICE WAS RETURNED FOR ANALYSIS." }, { "mdr_text_key": "192058384", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME." }, { "mdr_text_key": "192058385", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A FLASHING DISPLAY. IT WAS ALSO REPORTED THAT THE INSULIN PUMP ALARMED WITH HARDWARE LOW LEVEL FAILURES. CUSTOMER WAS ABLE TO CLEAR ALARM AND SELF TEST WAS PASSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS." } ], "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": "818", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/03/2020;01/31/2023" } ] }