{
  "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,
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    }
  },
  "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": "1823260-2020-01115",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200427",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K961481",
      "date_of_event": "20200405",
      "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": [
        "FOREIGN",
        "HEALTH PROFESSIONAL",
        "U"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "SA",
      "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": "464059",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200427",
          "brand_name": "COBAS E 411 IMMUNOASSAY ANALYZER",
          "generic_name": "IMMUNOCHEMISTRY ANALYZER",
          "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": "E411 DISK",
          "catalog_number": "4775279001",
          "lot_number": "NA",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "JJE",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.2160",
            "device_class": "1"
          }
        }
      ],
      "product_problems": [
        "High Test Results",
        "High Test Results"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "04/09/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250725",
      "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": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Consequences Or Impact To Patient",
            "No Consequences Or Impact To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200625",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000614",
      "removal_correction_number": "NA",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200409",
      "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": "201736989",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THIS EVENT OCCURRED IN (B)(6). CALIBRATION AND QUALITY CONTROL WERE ACCEPTABLE."
        },
        {
          "mdr_text_key": "201736990",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE INITIAL REPORTER RECEIVED A QUESTIONABLE HIGH TROPONIN T HIGH SENSITIVE STAT RESULT FOR ONE PATIENT FROM A COBAS E411 DISK. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING FOR CONFIRMATION. ON (B)(6) 2020, THE PATIENT¿S INITIAL TROPONIN RESULT WAS 486.7 PG/ML WITH A DATA FLAG. ON (B)(6) 2020, THE PATIENT¿S REPEAT TROPONIN RESULT WAS 8.17 PG/ML. THE CUSTOMER DETERMINED THE REPEAT RESULT WAS CORRECT. TROPONIN REAGENT LOT NUMBER WAS 381539 WITH AN EXPIRATION DATE OF (B)(6) 2020."
        },
        {
          "mdr_text_key": "316702182",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "BASED ON THE DATA PROVIDED THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED."
        }
      ],
      "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": "06/25/2020"
    }
  ]
}