{ "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": 399 } }, "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": "3016438761-2020-00062", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200506", "manufacturer_address_2": "", "pma_pmn_number": "K060574", "date_of_event": "20200319", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "KZ", "manufacturer_contact_area_code": "", "date_added": "20200506", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "492590", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200506", "brand_name": "TOTAL BILIRUBIN", "generic_name": "TOTAL BILIRUBIN REAGENT", "manufacturer_d_name": "ABBOTT LABORATORIES (IRVING IA/CC)", "manufacturer_d_address_1": "1915 HURD DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "IRVING", "manufacturer_d_state": "TX", "manufacturer_d_zip_code": "75038", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "75038", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20201231", "model_number": "6L45-41", "catalog_number": "06L45-41", "lot_number": "55406UQ07", "other_id_number": "", "device_availability": "No", "device_report_product_code": "CIG", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00380740011383", "udi_public": "00380740011383", "openfda": { "registration_number": [ "3016438761" ], "fei_number": [ "3016438761" ], "device_name": "Diazo Colorimetry, Bilirubin", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1110", "device_class": "2" } } ], "product_problems": [ "High Test Results", "High Test Results" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20200506", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "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": "20200506", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10028824", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200505", "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": "225929337", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A REVIEW OF TICKETS DETERMINED NORMAL COMPLAINT ACTIVITY FOR LOT 55406UQ07 AND NO TRENDS FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE TOTAL BILIRUBIN REAGENT AND ARCHITECT SYSTEM OPERATIONS MANUAL PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT TOTAL BILIRUBIN REAGENT, LOT 55406UQ07. THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1415939-2020-00031. THE SUSPECT MEDICAL DEVICE ARCHITECT TOTAL BILIRUBIN REAGENT, LIST NUMBER 06L45-41, LOT 55406UQ07, WAS FILED ON THE INCORRECT MANUFACTURING SITE ABBOTT LABORATORIES, (B)(4). THE CORRECT MANUFACTURING SITE IS ABBOTT LABORATORIES (B)(4)." }, { "mdr_text_key": "225929338", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER OBSERVED ERRATIC TOTAL BILIRUBIN RESULTS ON ONE PATIENT ON THE ARCHITECT C8000 ANALYZER, SERIAL NUMBER (B)(4). THE FOLLOWING DATA WAS PROVIDED: TOTAL BILIRUBIN = 5.4MMOL/L, DIRECT BILIRUBIN = 6.6. THE SAMPLE WAS TESTED ON ANOTHER ARCHITECT C8000, SERIAL NUMBER (B)(4) - TOTAL BILIRUBIN = 6.5MMOL/L, DIRECT BILIRUBIN = 7.0. THE SAMPLE WAS THEN RETESTED ON SN (B)(4) - TOTAL BILIRUBIN = 1.9MMOL/L, DIRECT BILIRUBIN = 5.9. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED." } ], "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": "" } ] }