{ "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": "2026-04-28", "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": "2032227-2026-151370", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260331", "manufacturer_address_2": "", "pma_pmn_number": "P160017", "date_of_event": "20260324", "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": "PENDYALA", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "00777-3869", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260331", "manufacturer_contact_f_name": "GOUTHAM", "device_date_of_manufacturer": "20240514", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "260554", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260331", "brand_name": "PUMP MMT-1884L MM780G BLE 3.0 MG/ML", "generic_name": "AUTOMATED INSULIN DOSING 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-1884L", "catalog_number": "MMT-1884L", "lot_number": "NG3777116H", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OZP", "device_age_text": "", "device_evaluated_by_manufacturer": "*", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Automated Insulin Dosing Device System, Single Hormonal Control", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Moisture or Humidity Problem", "Power Problem" ], "reporter_state_code": "AR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "*", "date_changed": "20260331", "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": "20260331", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "69 YR", "patient_sex": "Male", "patient_weight": "67 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260330", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "*", "manufacturer_contact_city": "JUNCOS", "mdr_report_key": "24737922", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260324", "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": "397939347", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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": "397939348", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED CRITICAL PUMP ERROR AND EXPOSED WITH WATER. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884L. TROUBLESHOOTING WAS PERFORMED. INSTRUCTED CUSTOMER THAT PUMP WILL BE REPLACED AND INSTRUCTED CUSTOMER TO REVERT TO BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS AND PLACE PUMP IN STORAGE MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884L WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CEIBA NORTE IND. 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