{ "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": "2026-09-29", "results": { "skip": 0, "limit": 1, "total": 59712 } }, "results": [ { "manufacturer_contact_zip_ext": "7001", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "1360 SOUTH LOOP ROAD", "manufacturer_contact_pcity": "41572054", "event_type": "Malfunction", "report_number": "2954323-2026-106815", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20260603", "manufacturer_address_2": "", "pma_pmn_number": "K212132", "date_of_event": "20260502", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94502", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4157205405", "noe_summarized": "1", "manufacturer_contact_l_name": "REIS CASTRO", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260603", "manufacturer_contact_f_name": "PATRICIA", "device_date_of_manufacturer": "20260122", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1433557", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260603", "brand_name": "FREESTYLE LIBRE 3", "generic_name": "CONTINUOUS GLUCOSE MONITORING SYSTEM", "manufacturer_d_name": "ABBOTT DIABETES CARE LTD", "manufacturer_d_address_1": "RANGE ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "WITNEY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "12345", "manufacturer_d_zip_code_ext": "-700", "manufacturer_d_country": "UK", "manufacturer_d_postal_code": "12345-7001", "device_operator": "LAY USER/PATIENT", "model_number": "72081-01", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "QLG", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00357599818005", "udi_public": "(01)00357599818005(17)2026-10-31(10)T60004044(91)72081-01", "openfda": { "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1355", "device_class": "2" } } ], "product_problems": [ "Low Readings" ], "reporter_state_code": "NM", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/09/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260717", "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": "20260603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260703", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "ALAMEDA", "mdr_report_key": "25369348", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260505", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "404591724", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED." }, { "mdr_text_key": "404591725", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A CUSTOMER REPORTED RECEIVING LOW GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 50 MG/DL COMPARED TO READINGS OF 198 MG/DL RESPECTIVELY OBTAINED ON A COMPETITOR BRAND METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS DAY 1. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "945027001", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/03/2026" } ] }