{ "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": 2943 } }, "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": "8031673-2020-00127", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200507", "manufacturer_address_2": "", "pma_pmn_number": "K971103", "date_of_event": "20191009", "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": [ "DISTRIBUTOR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "CA", "manufacturer_contact_area_code": "", "date_added": "20200507", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "498965", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20200507", "brand_name": "TOSOH HLC-723G8 ANALYZER G8", "generic_name": "G8", "manufacturer_d_name": "TOSOH CORPORATION", "manufacturer_d_address_1": "SHIBA-KOEN FIRST BUILDING", "manufacturer_d_address_2": "3-8-2 SHIBA", "manufacturer_d_city": "MINATO-KU,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "10586", "manufacturer_d_zip_code_ext": "23", "manufacturer_d_country": "JA", "manufacturer_d_postal_code": "1058623", "device_operator": "HEALTH PROFESSIONAL", "model_number": "G8", "catalog_number": "021560", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200717", "device_report_product_code": "LCP", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Assay, Glycosylated Hemoglobin", "medical_specialty_description": "Hematology", "regulation_number": "864.7470", "device_class": "2", "registration_number": [ "8031673" ], "fei_number": [ "2967" ] } } ], "product_problems": [ "Fire", "Smoking", null, "Fire", "Smoking" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/26/2020;08/26/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20200507", "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": "20210512", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10036714", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200415", "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": "190267092", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW THROUGH AWARE DATE OF EVENT FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4). THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS PENDING INVESTIGATION COMPLETION." }, { "mdr_text_key": "190267093", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A DISTRIBUTOR REPORTED A TOSOH G8 INSTRUMENT AT A CUSTOMER'S SITE HAD SMOKE/FIRE COMING FROM THE BACK OF THE INSTRUMENT WHILE IN USE. THIS INCIDENT OCCURRED ON (B)(6) 2019 BUT WAS REPORTED TO TOSOH ON (B)(6) 2020. TOSOH WAS INFORMED THAT THE CUSTOMER UNPLUGGED THE INSTRUMENT AND THE SMOKE/FIRE WENT OUT. NO USERS WERE INJURED, AND THERE WAS NO PERMANENT PROPERTY DAMAGE BEYOND THE INSTRUMENT 'S REAR ELECTRICAL PLUG AND REAGENT CONTAINER IN NEAREST PROXIMITY. THE DISTRIBUTOR WENT TO THE CUSTOMER'S SITE TO INVESTIGATE AND DISCOVERED SEVERELY MELTED/DAMAGED POWER CORD AT INSTRUMENT ATTACHMENT. TESTING OF POWER OUTLET DID NOT REVEAL ANY OUT-OF-SPECIFICATION ELECTRICAL FLUCTUATIONS. NO SIGNS OF BURNING WITHIN INSTRUMENT. THE INSTRUMENT HAS BEEN SHIPPED TO TOSOH FOR FURTHER INVESTIGATION. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT." }, { "mdr_text_key": "323292165", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "N/A." }, { "mdr_text_key": "323292166", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(6) 2020 WAS INCORRECTED ENTERED IN BOTH MDR 8031673-2020-00127 AND 8031673-2020-00127_FOLLOW UP1. THIS SUPPLEMENTAL IS TO CORRECT THE DATE OF EVENT TO (B)(6) 2019." }, { "mdr_text_key": "311589477", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE G8 INSTRUMENT WAS RETURNED TO THE MANUFACTURER, TOSOH BIOSCIENCE, JAPAN FOR INVESTIGATION, BUT THE AFFECTED POWER SUPPLY CABLE FOR THE G8 INSTRUMENT WAS RETURNED TO KAWASAKI ELECTRIC WIRE CO. LTD. QA DEPARTMENT FOR INVESTIGATION ON BEHALF OF TOSOH AS THEY WERE THE MANUFACTURER OF THE POWER CABLE. THE EXTERNAL APPEARANCE OF THE RETURNED PRODUCT WAS INSPECTED AND FOUND THE CODE MARKINGS ON THE POWER CABLE INDICATED THAT THE CABLE WAS PRODUCED IN 2009. THE PLUG HAD SOME DIRT BUT NO DAMAGE, AND THE CONNECTOR WAS HEAVILY DAMAGED. AN X-RAY TRANSMISSION CHECK WAS PERFORMED ON THE CABLE, AND RESULT FOUND THE CONNECTOR BODY WAS SEVERELY DAMAGED AND THE BLADE CATCHER WAS BURNED OUT. NO ABNORMALITY (CRIMPING ABNORMALITY, BROKEN CONDUCTOR, ETC.) WAS FOUND TO BE A CAUSE OF IGNITION AT ANY POINT. MANUFACTURER CONFIRMED THE REPORTED G8 FIRE AT THE CUSTOMER'S SITE WAS DUE TO BURNED OUT CONNECTOR OF THE POWER CABLE." }, { "mdr_text_key": "311589478", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "N/A." } ], "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": "12/23/2020;05/13/2021" } ] }