{ "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": 2803272 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2032227-2020-110202", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200418", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "CONSUMER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "465755", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "630G INSULIN PUMP MMT-1715K 630G BLACK MG", "generic_name": "ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND", "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-1715K", "catalog_number": "MMT-1715K", "lot_number": "HG1B44Y", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200429", "device_report_product_code": "OZO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00643169656840", "udi_public": "(01)00643169656840", "openfda": { "registration_number": [ "2032227" ], "fei_number": [ "3003166194" ], "device_name": "Automated Insulin Dosing , Threshold Suspend", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Battery Problem", "Power Problem", "Battery Problem", "Power Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/03/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "111", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200605", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000053", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200421", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "194228301", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE PASSED SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, SELF TEST AND DISPLACEMENT TEST. HOWEVER, DEVICE TRACE DOWNLOAD ANALYSIS CONFIRMED THE INSULIN PUMP ALARMED POWER ERROR 25, POWER LOSS ALARM, REPLACE BATTERY ALERT AND REPLACE BATTERY NOW ALARM. THE ADAPT TOOL CONFIRMED POWER ERROR 25, POWER LOSS ALARM, REPLACE BATTERY ALERT, REPLACE BATTERY NOW ALARM WAS TRIGGERED WHEN THE BACKUP BATTERY LOADED VOLTAGE (LOADED VLITH) WAS LESS THAN 3.5V FOR 4 CONSECUTIVE HOURS DUE TO CONNECTOR RESISTANCE ELECTRICAL BOARD. AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON ELECTRICAL BOARD, DEVICE WAS MONITORED AND FUNCTIONED PROPERLY." }, { "mdr_text_key": "192358988", "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 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." }, { "mdr_text_key": "192358989", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED WITH ALARM GENERATED WHEN A POWER SYSTEM ERROR WAS DETECTED AND THIS ERROR DOES NOT PREVENT THE PUMP FROM RUNNING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER ALSO REPORTED EXPERIENCING POWER ERROR FOR 3 DAYS. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR POWER ERROR ALARM. CUSTOMER WAS ADVISED TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/05/2020" } ] }