{ "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": 1114254 } }, "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": "Injury", "report_number": "2032227-2020-110177", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200420", "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": "464697", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "RESERVOIR 3ML MMT-332A", "generic_name": "PUMP, INFUSION", "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": "20230111", "model_number": "MMT-332A", "catalog_number": "MMT-332A", "lot_number": "HG40VF5", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200501", "device_report_product_code": "FRN", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "20763000273358", "udi_public": "(01)20763000273358(17)230111(10)HG40VF5", "openfda": { "registration_number": [ "2032227" ], "fei_number": [ "3003166194" ], "device_name": "Pump, Infusion", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ], "product_problems": [ "Excess Flow or Over-Infusion", "Excess Flow or Over-Infusion" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/05/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "68 YR", "patient_sex": "", "patient_weight": "102", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hypoglycemia", "Hypoglycemia" ] } ], "distributor_city": "", "date_report": "20200507", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000010", "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": "188979128", "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": "188979129", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 40 MG/DL AND 56 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER'S OTHER BLOOD GLUCOSE LEVELS WERE 150 MG/DL, 51 MG/DL, 173 MG/DL, 56 MG/DL AND 69 MG/DL. CUSTOMER USED FOOD TO TREAT. CUSTOMER HAD ALLEGED THAT THE INSULIN PUMP WAS OVER DELIVERING BECAUSE THE INSULIN PUMP KEPT GIVING INSULIN WHEN SHE WAS LOW. THE INSULIN SQUIRTED OUT FROM THE END OF THE SET. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER WAS USING AUTO MODE FEATURE. THE DEVICE WILL BE RETURNED FOR ANALYSIS." }, { "mdr_text_key": "190101536", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVALUATED 1 OPEN/USED RESERVOIR. INSPECTED RESERVOIR'S O-RINGS/STOPPER GROOVE FOR ANOMALIES. NONE WERE FOUND. RAN BASAL, BOLUS LEAKING TEST PER DOP114-811 AS FOLLOWS: RESERVOIR FILLED WITH DILUENT AND CONNECTED TO A NEW INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR INTO A PARADIGM PUMP. ALSO, PERFORMED PRE- FILL TEST TO RESERVOIR AND THERE WAS NO LEAKING AROUND TRANSFER GUARD AREA. CONCLUSION: RESERVOIR DOES NOT LEAK. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5." } ], "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": "05/07/2020" } ] }