{ "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": 362 } }, "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": "2517506-2020-00150", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200511", "manufacturer_address_2": "", "pma_pmn_number": "K130276", "date_of_event": "20200416", "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": [ "HEALTH PROFESSIONAL", "USER FACI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200511", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "506188", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200511", "brand_name": "DIMENSION®", "generic_name": "DIMENSION® LOCI CARDIAC TROPONIN I CALIBRATOR", "manufacturer_d_name": "SIEMENS HEALTHCARE DIAGNOSTICS INC", "manufacturer_d_address_1": "500 GBC DRIVE", "manufacturer_d_address_2": "P.O. 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SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) COMPLETED THE INVESTIGATION OF THE EVENT. A REVIEW OF THE CALIBRATION PERFORMED ON 16-APR-2020 SHOWED SHIFTS IN THE REACTION SIGNAL THAT INDICATE THERE WAS A POTENTIAL ISSUE WITH THE STORAGE OR HANDLING OF THE CALIBRATOR CAUSING THE SHIFT IN QUALITY CONTROL AND PATIENT PERFORMANCE. THE CAUSE OF THE ELEVATED TROPONIN WITH SAMPLES AND QC WAS AN ISSUE WITH THE CALIBRATION ON 16-APR-2020 WHICH WAS RESOLVED WITH THE CALIBRATION PERFORMED ON 17-APR-2020 ON THE ORIGINAL INSTRUMENT DIMENSION EXL S/N (B)(4). THERE IS NO EVIDENCE OF A PRODUCT NON-CONFORMANCE. THE CUSTOMER IS OPERATIONAL. THE SYSTEM IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED." }, { "mdr_text_key": "195657381", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN WHEN OUT OF RANGE DAILY QUALITY CONTROL (QC) WAS NOTED. THE SAME SAMPLES WERE REPROCESSED THE SAME DAY OR THE NEXT DAY ON THE SAME INSTRUMENT AS WELL AS ON AN ALTERNATE DIMENSION INSTRUMENT, LOWER CORRECT RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI RESULTS." } ], "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": "" } ] }