{ "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": "2026-10-07", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "CHAPEL LANE", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "NY", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SWORDS, CO, DUBLIN", "manufacturer_contact_address_1": "511 BENEDICT AVE", "manufacturer_contact_pcity": "91425505", "event_type": "Malfunction", "report_number": "2432235-2022-00213", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220803", "manufacturer_address_2": "", "pma_pmn_number": "EXEMPT", "date_of_event": "20220712", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "10591", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "9142550572", "noe_summarized": "1", "manufacturer_contact_l_name": "AEBIG", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "10040", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "914", "date_added": "20220803", "manufacturer_contact_f_name": "KARL", "device_date_of_manufacturer": "20220306", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1393929", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20220803", "brand_name": "ATELLICA DATA MANAGER", "generic_name": "ATELLICA DATA MANAGER", "manufacturer_d_name": "SIEMENS HEALTHCARE DIAGNOSTICS INC.", "manufacturer_d_address_1": "511 BENEDICT AVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "TARRYTOWN", "manufacturer_d_state": "NY", "manufacturer_d_zip_code": "10591", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "10591", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ATELLICA DATA MANAGER", "catalog_number": "11314429", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "JQP", "device_age_text": "", "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": [ "Communication or Transmission Problem", "Communication or Transmission Problem" ], "reporter_state_code": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250801", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9142", "patient": [ { "patient_sequence_number": "1", "date_received": "20220803", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "47 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220803", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TARRYTOWN", "mdr_report_key": "15156960", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220712", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "10040", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "304798441", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ONE FALSELY ELEVATED PROSTATE SPECIFIC ANTIGEN (PSA) TEST RESULT ON ONE PATIENT SAMPLE WAS REPORTED TO A PHYSICIAN(S) WHEN THE LABORATORY'S LABDAQ LABORATORY INFORMATION SYSTEM (LIS) MISMANAGED THE \"RESULT ASPECT CODES\" IT RECEIVED FROM THE ATELLICA DATA MANAGER (ADM). THE ADM WAS RECONFIGURED TO NOT SEND \"RESULT ASPECT CODES\" AND THE CORRECT PSA TEST RESULT WAS RETRANSMITTED FROM THE ADM TO THE LABDAQ. THE RETRANSMITTED TEST RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT." }, { "mdr_text_key": "304798442", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT ONE FALSELY ELEVATED PROSTATE SPECIFIC ANTIGEN (PSA) TEST RESULT ON ONE PATIENT SAMPLE WAS REPORTED TO A PHYSICIAN(S) WHEN THE LABORATORY'S LABDAQ LABORATORY INFORMATION SYSTEM (LIS) MISMANAGED THE \"RESULT ASPECT CODES\" IT RECEIVED FROM THE ATELLICA DATA MANAGER (ADM). A SIEMENS CUSTOMER SERVICE (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INSPECT THE ADM. THE CSE DESELECTED THE OPTION IN ADM TO TRANSMIT \"RESULT ASPECT CODES\" TO AN LIS AND RETRANSMITTED THE TEST RESULT, RESOLVING THE EVENT. SIEMENS EVALUATED THE AVAILABLE INFORMATION AND FOUND THAT WHEN THE ADM TRANSMITS \"RESULT ASPECT CODES\" NON-TEST RESULT DATA (E.G., RLU AND COFF), IS TRANSMITTED TO THE LIS. THE LIS WAS IMPROPERLY CONFIGURED TO MANAGE \"RESULT ASPECT CODES\" AND SWAPPED A \"RESULT ASPECT CODE\" FOR THE ACTUAL TEST RESULT. IT WAS ALSO FOUND THAT ADM TO LIS TESTING DURING ADM VALIDATION USED A \"TEST\" CHANNEL WITH \"RESULT ASPECT CODES\" DESELECTED. WHEN THE CUSTOMER WENT LIVE WITH THE ADM A DIFFERENT CHANNEL WAS USED AND THAT CHANNEL WAS CONFIGURED TO SEND \"RESULT ASPECT CODES\". THE CAUSE OF THE FALSELY ELEVATED PSA TEST RESULT WAS AN ADM CONFIGURATION SETTING THAT WAS NOT SUPPORTED BY THE LIS. THE ANALYZER IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS ANALYZER IS NEEDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "REGISTRATION #: 8020888", "distributor_zip_code": "", "manufacturer_contact_postal_code": "10591", "manufacturer_contact_exchange": "914", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }