{ "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": 1004841 } }, "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": "3002769706-2020-00006", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K121461", "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", "U" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "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": "467053", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "BACT/ALERT FA PLUS", "generic_name": "BACT/ALERT® FA PLUS", "manufacturer_d_name": "BIOMERIEUX INC.", "manufacturer_d_address_1": "100 RODOLPHE STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "DURHAM", "manufacturer_d_state": "NC", "manufacturer_d_zip_code": "27712", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "27712", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20201015", "model_number": "", "catalog_number": "410851", "lot_number": "0004054600", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MDB", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "03573026357900", "udi_public": "03573026357900", "openfda": { "registration_number": [ "3002769706" ], "fei_number": [ "3002769706" ], "device_name": "System, Blood Culturing", "medical_specialty_description": "Microbiology", "regulation_number": "866.2560", "device_class": "1" } } ], "product_problems": [ "Device Markings/Labelling Problem", "Device Markings/Labelling Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/03/2020", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "", "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": "20201229", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000178", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200403", "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": "188987799", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DUPLICATE BOTTLE BARCODES IN ASSOCIATION WITH THE BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE (REF. 410851, LOT 0004054600). THE CUSTOMER STATED THAT THEY LOADED THE INOCULATED BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE ONTO THE BACT/ALERT® 3D INSTRUMENT; THE INSTRUMENT IMMEDIATELY REGISTERED THE BOTTLE AS NEGATIVE. THE CUSTOMER REVIEWED THE RESULT-EDITING SCREEN, WHICH SHOWED THIS BOTTLE ID HAD BEEN LOADED ONTO THE INSTRUMENT ON (B)(6) 2020 AND REMOVED ON (B)(6) 2020. THE NEW BOTTLE WAS EJECTED UPON IDENTIFYING THE DUPLICATE BOTTLE BARCODE. THE USER MUST RELOAD THE BOTTLE WITH A GENERIC BOTTLE LABEL IN ORDER FOR IT TO BE FULLY PROCESSED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION." }, { "mdr_text_key": "321679584", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN JAPAN REGARDING DUPLICATE BOTTLE BARCODES IN ASSOCIATION WITH THE BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE (REF. 410851, LOT 0004054600). THE CUSTOMER STATED THEY LOADED THE INOCULATED BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE ONTO THE BACT/ALERT® 3D INSTRUMENT; THE INSTRUMENT IMMEDIATELY REGISTERED THE BOTTLE AS NEGATIVE. THE CUSTOMER REVIEWED THE RESULT-EDITING SCREEN, WHICH SHOWED THE BOTTLE ID HAD BEEN LOADED ONTO THE INSTRUMENT ON A PREVIOUS DATE. A TECHNICAL ASSESSMENT FROM THE MANUFACTURING FACILITY EVALUATED THE DUPLICATE BOTTLE ID CODES ON BACT/ALERT® BOTTLE LABELS. IT WAS DETERMINED THAT AS THE BACT/ALERT® PRODUCTS WERE TRANSITIONING TO THE NEW UDI (UNIQUE DEVICE IDENTIFIER) PACKAGING LINE, SEVERAL FA PLUS AND FN PLUS LOTS CONTINUED TO BE PACKAGED ON THE LEGACY (OLD STYLE) PACKAGING LINE, CREATING AN OVERLAP OF BOTTLE IDENTIFICATION CODES. BACT/ALERT® BOTTLES AFFECTED BY THIS ANOMALY WERE LIMITED TO FA PLUS (P/N 410851) AND FN PLUS (410852) PRODUCT TYPES AND SPECIFIC LOT NUMBERS. A TECHNICAL ASSESSMENT FROM THE MANUFACTURING FACILITY EVALUATED THE DUPLICATE BOTTLE ID CODES ON BACT/ALERT® BOTTLE LABELS. IT WAS DETERMINED THAT AS THE BACT/ALERT® PRODUCTS WERE TRANSITIONING TO THE NEW UDI (UNIQUE DEVICE IDENTIFIER) PACKAGING LINE, SEVERAL FA PLUS AND FN PLUS LOTS CONTINUED TO BE PACKAGED ON THE LEGACY (OLD STYLE) PACKAGING LINE, CREATING AN OVERLAP OF BOTTLE IDENTIFICATION CODES. BACT/ALERT® BOTTLES AFFECTED BY THIS ANOMALY WERE LIMITED TO FA PLUS (P/N 410851) AND FN PLUS (410852) PRODUCT TYPES AND SPECIFIC LOT NUMBERS. FURTHER EVALUATION OF THE ROOT CAUSE WAS CONDUCTED THROUGH CAPA 1710602, WHICH WAS INITIATED BY THE MANUFACTURING SITE. IT WAS DETERMINED THAT PERSONNEL WAS THE PRIMARY ROOT CAUSE. THE AUTOMATION ENGINEER HAD THE KNOWLEDGE/SKILL SET TO EXECUTE THE TASK BUT APPLIED THE INCORRECT ACTION THAT RESULTED IN THE DUPLICATE BOTTLE IDS ON THE LABELS OF SEVERAL BACT/ALERT® FA PLUS AND FN PLUS BOTTLES. PROCESS-DOCUMENTATION WAS A SECONDARY ROOT CAUSE. THERE WERE NO VERIFICATION STEPS TO CHECK THE SOFTWARE UPDATES, OR PROCESSES IN PLACE TO DETECT DUPLICATE BOTTLE IDS. PREVENTIVE ACTIONS WERE RECOMMENDED TO ADDRESS THE ROOT CAUSES AND ARE CURRENTLY IN PROGRESS AT THE TIME OF THIS REPORT. BIOMÉRIEUX ASSESSED THE RISK ASSOCIATED WITH THIS ISSUE AND DETERMINED THAT THE OVERALL RISK IS MINOR. GLOBAL CUSTOMER SERVICE (GCS) ADVISED SEVERAL POINTS TO COMMUNICATE APPROPRIATE BOTTLE HANDLING TO THE CUSTOMERS IN CASE OF A DUPLICATE BACT/ALERT® BOTTLE ID. ALL LOTS INVOLVED IN THE DUPLICATE BOTTLE IDENTIFICATION CODES ARE NOW EXPIRED AS OF 04NOV2020.SEE SECTION H10." } ], "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": "12/29/2020" } ] }