{ "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": "2026-06-11", "results": { "skip": 0, "limit": 1, "total": 1 } }, "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": "2954323-2026-55442", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260430", "manufacturer_address_2": "", "pma_pmn_number": "K223435", "date_of_event": "20251022", "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": "415", "date_added": "20260430", "manufacturer_contact_f_name": "PATRICIA", "device_date_of_manufacturer": "20250817", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "396368", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260430", "brand_name": "FREESTYLE LIBRE 3 PLUS", "generic_name": "CONTINUOUS GLUCOSE MONITORING SYSTEM", "manufacturer_d_name": "ABBOTT DIABETES CARE INC", "manufacturer_d_address_1": "1360 SOUTH LOOP ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "ALAMEDA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94502", "manufacturer_d_zip_code_ext": "7001", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "945027001", "device_operator": "LAY USER/PATIENT", "expiration_date_of_device": "20260430", "model_number": "78768-01", "catalog_number": "", "lot_number": "T60003544", "other_id_number": "", "device_availability": "No", "device_report_product_code": "QBJ", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00357599844011", "udi_public": "(01)00357599844011(17)2026-04-30(10)T60003544(91)78768-01", "openfda": { "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1355", "device_class": "2" } } ], "product_problems": [ "Low Readings" ], "reporter_state_code": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260522", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4157", "patient": [ { "patient_sequence_number": "1", "date_received": "20260430", "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": "20260429", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "ALAMEDA", "mdr_report_key": "25038624", "removal_correction_number": "2954323-11/22/25-001-C", "number_devices_in_event": "", "date_manufacturer_received": "20251022", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Recall" ], "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": "400978850", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADC INVESTIGATED THIS ISSUE AND DETERMINED THAT THE SENSOR ASSOCIATED WITH THIS COMPLAINT MAY NOT MEET PRODUCT DESIGN SPECIFICATIONS AND MAY PRODUCE LOW GLUCOSE READINGS WHICH ARE NOT CLINICALLY ACCEPTABLE. THIS PRODUCT HAS BEEN DETERMINED TO BE WITHIN THE SCOPE OF THE INVESTIGATION AND ACTIONS CONDUCTED UNDER ADC FIELD ACTION FA1002-2025. NO FURTHER INVESTIGATION ACTIONS ARE REQUIRED AS THIS ISSUE IS CONFIRMED TO BE IN THE SCOPE OF ADC FA1002-2025. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED." }, { "mdr_text_key": "400978851", "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. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY ADC FIELD ACTION FA1002-2025. IMPACTED PRODUCT WAS DISTRIBUTED TO ANDORRA, AUSTRIA, BELGIUM, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, ITALY, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, SAN MARINO, SPAIN, SWEDEN, SWITZERLAND, UK, US, AND QATAR. ADC FIELD ACTION FA1002-2025 WAS ISSUED ONLY TO IMPACTED COUNTRIES. THIS REPORT IS BEING SUBMITTED AS PART OF RETROSPECTIVE REPORTING RELATED TO FA1002-2025. 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": "415", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }