{ "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": 2771 } }, "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": "3005094123-2020-00095", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200306", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "468658", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200428", "brand_name": "ARCHITECT TSH", "generic_name": "TSH", "manufacturer_d_name": "ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD", "manufacturer_d_address_1": "LISNAMUCK", "manufacturer_d_address_2": "CO. LONGFORD", "manufacturer_d_city": "LONGFORD", "manufacturer_d_state": "", "manufacturer_d_zip_code": "NA", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "NA", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210118", "model_number": "7K62-25", "catalog_number": "07K62-25", "lot_number": "06406UI00", "other_id_number": "", "device_availability": "No", "device_report_product_code": "JLW", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00380740014230", "udi_public": "00380740014230", "openfda": { "registration_number": [ "3005094123" ], "fei_number": [ "3005094123" ], "device_name": "Radioimmunoassay, Thyroid-Stimulating Hormone", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1690", "device_class": "2" } } ], "product_problems": [ "Low Test Results", "Low Test Results" ], "reporter_state_code": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20200428", "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": "20200428", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10006207", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "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": "200478651", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. A REVIEW OF TICKETS WAS PERFORMED FOR REAGENT LOT NUMBER 06406UI00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT LOT NUMBER 06406UI00 AND ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEM ISSUE OR DEFICIENCY OF THE ARCHITECT TSH ASSAY FOR LOT 06406UI00 WAS IDENTIFIED." }, { "mdr_text_key": "200478652", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE FOR ARCHITECT AND QUEST: 0.4 TO 4.5 UIU/ML): (B)(6) 2020 INITIAL RESULT = 0.09 UIU/ML, REPEAT AT QUEST = 1.30 UIU/ML, REPEATED ON ROCHE ANALYZER = 1.30 UIU/ML. FREE T3 AND FREE T4 RESULTS WERE NORMAL ACROSS ALL PLATFORMS. PATIENT IS CURRENTLY TAKING THYROID MEDICATION METHIIMAZOLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED." } ], "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": "" } ] }