{ "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": 1196063 } }, "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": "2032227-2020-110184", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200305", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "00777", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "8185464805", "noe_summarized": "1", "manufacturer_contact_l_name": "DE GRAAFF", "source_type": [ "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": "20171218", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "464955", "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": "HG27JUS", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200323", "device_report_product_code": "OZP", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00643169939219", "udi_public": "(01)00643169939219", "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": [ "No Apparent Adverse Event", "Patient Device Interaction Problem", "No Apparent Adverse Event", "Patient Device Interaction Problem" ], "reporter_state_code": "IN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/14/2019", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "N", "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": "52 YR", "patient_sex": "Female", "patient_weight": "153 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20220508", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "JUNCOS", "mdr_report_key": "10000026", "removal_correction_number": "Z-0956-2020", "number_devices_in_event": "", "date_manufacturer_received": "20200423", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Recall" ], "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": "192392061", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIT RECEIVED WITH MISSING RETAINER RING AND RESERVOIR TUBE LIP O-RING. UNIT RECEIVED WITH PARTIALLY BROKEN OFF PIECE AT THE RESERVOIR TUBE LIP. UNABLE TO PERFORM DISPLACEMENT TEST AND P-CAP / RESERVOIR WILL NOT LOCK PROPERLY DUE TO MISSING RETAINER. UNIT RECEIVED WITH FADED SERIAL NUMBER LABEL. UNIT RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CASE AND KEYPAD OVERLAY. (B)(4)." }, { "mdr_text_key": "192392062", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S RETAINER RING WAS CRACKED AND DAMAGED. THE CUSTOMER STATED THAT THE RESERVOIR DID LOCKED INTO PLACE WHEN INSERTED INTO INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS." }, { "mdr_text_key": "330271913", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0956-2020. 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." } ], "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": "05/08/2022" } ] }