{ "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": 423899 } }, "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": "1823260-2020-01111", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K062925", "date_of_event": "20200407", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "CONSUMER" ], "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": "466032", "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": "LAY USER/PATIENT", "expiration_date_of_device": "20210331", "model_number": "NA", "catalog_number": "04625374160", "lot_number": "41747423", "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": "20250818", "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": "74 YR", "patient_sex": "", "patient_weight": "95", "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": "10000069", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "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": "218020647", "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. REPORTER OCCUPATION: THE OCCUPATION IS LAY USER/PATIENT." }, { "mdr_text_key": "218020648", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE INITIAL REPORTER STATED HER HUSBAND RECEIVED DISCREPANT RESULTS WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 2:25 A.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING WITH A VALUE OF 4.3 INR. AT 3:29 A.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING WITH A VALUE OF 4.5 INR. AT 4 A.M., A SAMPLE FROM THE PATIENT WAS TESTED IN THE LABORATORY USING AN UNKNOWN METHOD, RESULTING WITH A VALUE OF 3.0 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.0 - 3.0 INR. 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