{ "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": 689706 } }, "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": "2032227-2020-110216", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200213", "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": "20180620", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "466275", "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", "expiration_date_of_device": "20210619", "model_number": "MMT-1715K", "catalog_number": "MMT-1715K", "lot_number": "HG2MBVA", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200313", "device_report_product_code": "OZO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00763000090197", "udi_public": "(01)00763000090197(17)210619", "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": [ "Patient Device Interaction Problem", "Patient Device Interaction Problem" ], "reporter_state_code": "FL", "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": "65 YR", "patient_sex": "Female", "patient_weight": "130 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20220507", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "JUNCOS", "mdr_report_key": "10000075", "removal_correction_number": "Z-0955-2020", "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": "330259157", "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-0955-2020. 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." }, { "mdr_text_key": "191869984", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PUMP WAS RECEIVED WITH PARTIALLY BROKEN RESERVOIR TUBE LIP, MISSING RETAINER, MISSING RESERVOIR TUBE O-RING, CASE CRACKED BEHIND THE PUMP NEAR THE BATTERY COMPARTMENT AND CRACKED BATTERY TUBE THREADS. A TEST P-CAP AND RESERVOIR WAS INSTALLED AND DID NOT LOCK IN PLACE DUE TO BROKEN RESERVOIR TUBE LIP AND MISSING RETAINER. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO BROKEN RESERVOIR TUBE LIP AND MISSING RETAINER. (B)(4)." }, { "mdr_text_key": "191869985", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PLASTIC PIECE FROM WHERE THE RESERVOIR GOES IN, WAS MISSING. CUSTOMER STATED THAT THE RESERVOIR DID LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER STATED THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER STATED THE INFUSION SET AND RESERVOIR DID NOT SHOW SIGNS OF DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. 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": "05/07/2022" } ] }