{ "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": 27 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "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": "2050012-2012-01228", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20120608", "manufacturer_address_2": "", "pma_pmn_number": "K961274", "date_of_event": "20120517", "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": [ "Foreign", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "EI", "manufacturer_contact_area_code": "", "date_added": "20121009", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120608", "brand_name": "BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER", "generic_name": "ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE", "manufacturer_d_name": "BECKMAN COULTER, INC.", "manufacturer_d_address_1": "250 S. KRAEMER BLVD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "BREA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92821", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92821", "device_operator": "HEALTH PROFESSIONAL", "model_number": "AU681-03E", "catalog_number": "N3147300", "lot_number": "NA", "other_id_number": "SOFTWARE V. 3.5", "device_availability": "Yes", "device_report_product_code": "JGS", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Electrode, Ion Specific, Sodium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1665", "device_class": "2" } } ], "product_problems": [ "Air Leak", "Incorrect Or Inadequate 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": "20120608", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "29 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20120517", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2605371", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20120517", "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": "2788849", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER GENERATED AN ERRONEOUS SODIUM RESULT OF 126 MMOL/L FOR ONE PATIENT. THE RESULT DID NOT FIT WITH THE PATIENT'S OTHER TEST RESULTS, AND WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED A HIGHER RESULT OF 134 MMOL/L. THERE WAS NO CHANGE TO PATIENT TREATMENT ASSOCIATED TO THIS EVENT. THE SAMPLE WAS ANALYZED FROM THE PRIMARY TUBE WHICH WAS CENTRIFUGED AT 4000RPM FOR 5 MINUTES. QC RESULTS WERE ACCEPTABLE AT THE TIME OF THE EVENT. FIELD SERVICE ENGINEER (FSE) NOTED THAT THE ISE (ION SELECTIVE ELECTRODE) WAS NOT CALIBRATING PROPERLY AND THEN DISCOVERED BUBBLES IN THE ISE SYSTEM. THE FSE REPLACED REFERENCE VALVE AND REFERENCE TUBING, AND VALIDATED THE INSTRUMENT PERFORMANCE. NO FURTHER ISE ISSUES HAVE BEEN NOTED." } ], "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": "" } ] }