{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 329340 } }, "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": "1823260-2020-01112", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K062925", "date_of_event": "20200323", "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": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "466781", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "COAGUCHEK ® XS SYSTEM", "generic_name": "PROTHROMBIN TIME TEST STRIPS", "manufacturer_d_name": "ROCHE DIAGNOSTICS", "manufacturer_d_address_1": "9115 HAGUE ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "INDIANAPOLIS", "manufacturer_d_state": "IN", "manufacturer_d_zip_code": "46250", "manufacturer_d_zip_code_ext": "0457", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "462500457", "device_operator": "HEALTH PROFESSIONAL", "model_number": "NA", "catalog_number": "04625315160", "lot_number": "ASKU", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GJS", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Test, Time, Prothrombin", "medical_specialty_description": "Hematology", "regulation_number": "864.7750", "device_class": "2" } } ], "product_problems": [ "High Test Results", "High Test Results" ], "reporter_state_code": "", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "74", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000197", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "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": "241260382", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE REPORTER'S PRODUCT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE REPORTER. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED.COAGUCHEK USES HUMAN RECOMBINANT THROMBOPLASTIN. THEREFORE, COMPARABILITY TO OTHER HUMAN RECOMBINANT THROMBOPLASTINS IS BEST, WHEREAS HIGHER DEVIATIONS CAN OCCUR WITH OTHER THROMBOPLASTINS. HOWEVER, THOSE HIGHER DIFFERENCES BETWEEN THROMBOPLASTINS OF DIFFERENT (RABBIT, BOVINE BASED) ORIGIN ARE NOT A COAGUCHEK SPECIFIC ISSUE. SIMILAR DIFFERENCES CAN BE OBSERVED WHEN A HUMAN RECOMBINANT THROMBOPLASTIN-BASED LABORATORY METHOD IS COMPARED AGAINST SEVERAL OTHER (RABBIT, BOVINE-BASED) LABORATORY METHODS." }, { "mdr_text_key": "241260383", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT TESTED WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 11:03 A.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING WITH A VALUE OF 8.0 INR. AT THE SAME TIME, A SAMPLE FROM THE PATIENT WAS TESTED IN THE LABORATORY USING AN UNKNOWN METHOD, RESULTING WITH A VALUE OF 5.7 INR. AT 11:17 A.M. ON (B)(6) 2020, A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING WITH A VALUE OF 4.8 INR. AT THE SAME TIME, A SAMPLE FROM THE PATIENT WAS TESTED IN THE LABORATORY USING AN UNKNOWN METHOD, RESULTING WITH A VALUE OF 3.5 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2 -3 INR." } ], "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": "" } ] }