{ "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": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 672 } }, "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": "1810909-2020-00217", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200501", "manufacturer_address_2": "", "pma_pmn_number": "K151742", "date_of_event": "20200403", "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": "20200501", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "480732", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20200501", "brand_name": "CONTOUR NEXT", "generic_name": "QUALITY CONTROL MATERIAL", "manufacturer_d_name": "ASCENSIA DIABETES CARE US INC.", "manufacturer_d_address_1": "100 SUMMIT LAKE DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "VALHALLA, NY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "LAY USER/PATIENT", "expiration_date_of_device": "20210430", "model_number": "7314", "catalog_number": "7314", "lot_number": "9BV2G52", "other_id_number": "", "device_availability": "No", "device_report_product_code": "JJX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10301937314015", "udi_public": "10301937314015", "openfda": { "registration_number": [ "1810909" ], "fei_number": [ "1810909" ], "device_name": "Single (Specified) Analyte Controls (Assayed And Unassayed)", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1660", "device_class": "1" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/24/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20200501", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200403", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10016800", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200403", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Replace" ], "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": "194555524", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DUE TO THE COVID-19 PANDEMIC, THE INVESTIGATION FOR THIS EVENT WILL BE DELAYED. WE WILL HOWEVER, SEND THE FOLLOW-UP REPORT AS SOON AS OUR LABORATORY SERVICES ARE ABLE TO RETURN TO NORMAL. THE PATIENT/FAMILY WAS THE INITIAL REPORTER , SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED." }, { "mdr_text_key": "194555525", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER REPORTED THAT HE RAN CONTROL TESTS ON THE CONTOUR NEXT ONE METER AND OBTAINED READINGS OF 123 MG/DL, 131 MG/DL AND 139 MG/DL. THE METER DID NOT AUTOMATICALLY MARK THEM AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER." }, { "mdr_text_key": "315316490", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, THE IN-HOUSE CONTOUR NEXT ONE METER WAS TESTED WITH THE IN-HOUSE CONTOUR NEXT TEST STRIPS AND IN-HOUSE CONTOUR NEXT CONTROL SOLUTION FROM LOT # 9BV2G52, WHICH GAVE A SATISFACTORY PERFORMANCE. ALL CONTROL READINGS OBTAINED DURING IN-HOUSE TESTING WERE PROPERLY MARKED AS CONTROL TESTS." } ], "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": "10/02/2020" } ] }