{ "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": 236 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "Y", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "1003919", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080215", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20080208", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "report_date": "20080215", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20080229", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080215", "brand_name": "FISHER SURE-VUE SERUM/URINE HCG-STAT", "generic_name": "KIT, URINE PREGNACY TEST", "manufacturer_d_name": "INNOVACON INC.", "manufacturer_d_address_1": "A SUBSIDIARY OF INVERNESS MEDI", "manufacturer_d_address_2": "4106 SORRENTO VALLEY BLVD", "manufacturer_d_city": "SAN DIEGO", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92121", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92121", "device_operator": "OTHER", "model_number": "*", "catalog_number": "23900530", "lot_number": "7090052", "other_id_number": "*", "device_availability": "No", "device_report_product_code": "LCX", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Kit, Test, Pregnancy, Hcg, Over The Counter", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1155", "device_class": "2" } }, { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2", "date_received": "20080215", "brand_name": "FISHER SURE-VUE SERUM/URINE HCG-STAT KIT", "generic_name": "KIT, URINE PREGNANCY TEST", "manufacturer_d_name": "INNOVACON INC", "manufacturer_d_address_1": "A SUBSIDIARY OF INVERNESS MEDI", "manufacturer_d_address_2": "4106 SORRENTO VALLEY BLVD", "manufacturer_d_city": "SAN DIEGO", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92121", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92121", "device_operator": "INVALID DATA", "model_number": "*", "catalog_number": "23900530", "lot_number": "7070191", "other_id_number": "*", "device_availability": "No", "device_report_product_code": "LCX", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Kit, Test, Pregnancy, Hcg, Over The Counter", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1155", "device_class": "2" } } ], "product_problems": [ "False Positive Result" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20080215", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "28 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unknown (for use when the patient's condition is not known)" ] } ], "distributor_city": "", "date_report": "20080215", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1003919", "removal_correction_number": "", "number_devices_in_event": "", "date_report_to_fda": "20080215", "manufacturer_name": "", "report_source_code": "User Facility 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": "794640", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "FALSE POSITIVE RESULT OBTAINED BY HEALTH ASSISTANT PERFORMING QUALITATIVE URINE HCG PREGNANCY TEST ON PATIENT USING FISHER SURE-VUE SERUM/URINE HCG-STAT KIT LOT HCG7090052. THE TEST WAS REPEATED USING SAME KIT LOT AND THE SAME POSITIVE RESULT WAS OBTAINED. A POSITIVE RESULT WAS ALSO OBTAINED USING KIT LOT HCG7070191. HOWEVER, A NEGATIVE RESULT WAS OBTAINED ON THE SAME SPECIMEN USING KIT LOT HCG7070060. PATIENT WAS A POSTPARTUM PATIENT WHO DENIED HAVING INTERCOURSE SINCE DELIVERY APPROXIMATELY ONE MONTH PRIOR TO EVENT SO IT WAS EXPECTED THAT RESULT WOULD BE NEGATIVE. A BLOOD SPECIMEN WAS DRAWN ON THE PATIENT FOR A QUANTITATIVE HCG TEST PERFORMED IN THE CENTRAL LABORATORY WHICH CAME BACK NEGATIVE (<5 MIU/ML)." } ], "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": "" } ] }