{ "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": "2026-10-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "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": "2050012-2010-00479", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20100722", "manufacturer_address_2": "", "pma_pmn_number": "CLASS1EXMPT", "date_of_event": "20100623", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20111228", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100722", "brand_name": "DATA LINK DL2000 DATA MANAGER, COMMAND CENTRAL", "generic_name": "DL2000 DATA MANAGER", "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": "0", "model_number": "N/A", "catalog_number": "378250", "lot_number": "N/A", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "JQP", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Calculator/Data Processing Module, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ], "product_problems": [ "Display or Visual Feedback Problem", "Device Operates Differently Than Expected" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20100722", "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" ] } ], "distributor_city": "", "date_report": "20100721", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1767982", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20100628", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "17394436", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS THE LAB RE-USING THE SAME SAMPLE ID FOR TWO DIFFERENT TESTS ON DL2000 DATA MANAGEMENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE INITIAL SAMPLE ID WAS GENERATED ON (B)(6) 2008 TO TEST URINE CREATININE. ON (B)(6) 2010, THE SAME ID NUMBER WAS GENERATED FOR A DIFFERENT PATIENT FOR A SERUM BASIC METABOLIC PANEL, MAGNESIUM, AND PHOSPHORUS. THE INITIAL TEST WAS STILL PENDING WHEN THE NEW ORDER WAS DOWNLOADED ON (B)(6) 2010. THE CUSTOMER IGNORED THE MESSAGE FROM THE EVENT LOG \"TUBE XXX SENT TWICE WITH A DIFFERENT PATIENT\". THE UNIT REJECTED THE NEW PROGRAM SINCE IT HAD THE INITIAL PROGRAM STILL PENDING. THE UNIT ATTEMPTED TO RUN URINE CREATININE ON THE SERUM SAMPLE. THE RESULT WAS SUPPRESSED AND SINCE URINE CREATININE WAS NOT ORDERED FOR THIS PATIENT, THE ERROR WAS DISCOVERED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT." }, { "mdr_text_key": "17651585", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DL2000 DATA MANAGEMENT HAD BEEN CONFIGURED TO DELET PROGRAMMING >(B)(6). THE UNIT DID NOT CLEAR THE PROGRAMMING. THE DL2000 DATA MANAGEMENT DID POST MESSAGE OF \">1000 REQUESTS, ARCHIVE\"; HOWEVER, THE OPERATORS HAVE BEEN IGNORING THIS MESSAGE. HOTLINE CLEARED OLD PROGRAMMING AND REPAIRED DATA BASE. THE ROOT CAUSE FOR THIS EVENT IS CUSTOMER ERROR AND DL2000 DATA MANAGEMENT." } ], "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": "" } ] }