{ "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": 1305063 } }, "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": "Malfunction", "report_number": "2954323-2020-02927", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K092602", "date_of_event": "20200423", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "464392", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "FREESTYLE LITE", "generic_name": "BLOOD 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", "model_number": "70805-70", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200515", "device_report_product_code": "NBW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2954323" ], "fei_number": [ "3002803444" ], "device_name": "System, Test, Blood Glucose, Over The Counter", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1345", "device_class": "2" } } ], "product_problems": [ "Failure to Power Up", "Failure to Power Up" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/01/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "70 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200702", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000064", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200423", "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": "189222156", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN EXTENDED INVESTIGATION HAS BEEN CONDUCTED, WHICH INVOLVED A MANUFACTURING REVIEW (INCLUDING 5 YEARS OF DEVICE HISTORY RECORDS (DHRS)), PREVIOUS COMPLAINT AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS CONDUCTED FOR BLANK SCREEN ISSUES, PROCESS FAILURE MODE EFFECTS ANALYSES (PFMEAS), DESIGN CONTROLS, AND DESIGN FAILURE MODE EFFECTS ANALYSES (DFMEAS), RISK MANAGEMENT REPORTS, RISK EVALUATIONS, AND LABEL COPY. THE INVESTIGATION DID NOT IDENTIFY ANY INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. IF THE PRODUCT IS RETURNED, AN INVESTIGATION WILL BE PERFORMED. NOTE: THE DEVICE MANUFACTURER DATE FOR THE REPORTED METER SERIAL NUMBER IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE INITIAL REPORTER¿S PHONE NUMBER IS UNKNOWN AND THE NUMBER IS A PLACEHOLDER." }, { "mdr_text_key": "189222157", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT." }, { "mdr_text_key": "315039024", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. METER DID NOT POWER ON WITH BUTTON DEPRESSION OR TEST STRIP INSERTION. THE METER WAS DE-CASED AND INTERNAL VISUAL INSPECTION WAS PERFORMED. CONTAMINATION WAS OBSERVED, WHICH WAS CAUSED BY LIQUID INGRESS. ALTHOUGH GLUCOSE RESULTS MAY BE DELAYED, BLOOD GLUCOSE COULD BE DETERMINED BY ALTERNATE MEANS, INCLUDING USE OF ANOTHER BLOOD GLUCOSE METER, SEEING A PHYSICIAN (AS RECOMMENDED IN PRODUCT LABELING), OR BY SEEKING TREATMENT AT A HEALTH CARE FACILITY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THE INITIAL REPORTER¿S PHONE NUMBER IS UNKNOWN AND THE NUMBER IN E1 IS A PLACEHOLDER." }, { "mdr_text_key": "315039025", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/02/2020" } ] }