{
  "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": 2392
    }
  },
  "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": "2245578-2020-00052",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200428",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K940918",
      "date_of_event": "20200420",
      "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": [
        "DISTRIBUTOR",
        "HEALTH PROFESSION"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "HK",
      "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": "469333",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200428",
          "brand_name": "I-STAT EG7+ CARTRIDGE",
          "generic_name": "EG7+ CARTRIDGE",
          "manufacturer_d_name": "ABBOTT POINT OF CARE",
          "manufacturer_d_address_1": "400 COLLEGE ROAD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "PRINCETON, NJ",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "expiration_date_of_device": "20201017",
          "model_number": "NA",
          "catalog_number": "03P76-25",
          "lot_number": "N20049",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "CHL",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "10054749000040",
          "udi_public": "10054749000040",
          "openfda": {
            "registration_number": [
              "2245578"
            ],
            "fei_number": [
              "2245578"
            ],
            "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1120",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Incorrect, Inadequate or Imprecise Result or Readings",
        "Incorrect, Inadequate or Imprecise Result or Readings"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "05/28/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250731",
      "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 Information",
            "No Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200603",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10004265",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200420",
      "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": "315937724",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 05/28/2020. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AF (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR EG7+ LOT N20049."
        },
        {
          "mdr_text_key": "315937725",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "NA."
        },
        {
          "mdr_text_key": "198923671",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT."
        },
        {
          "mdr_text_key": "198923672",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF 2.9 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: UNK, COLLECTED: 07:55AM, TESTED: UNK, RESULT: 2.9MMOL/L. LAB, UNK, 07:55AM, 08:07AM, 4.3MMOL/L. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY."
        }
      ],
      "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": "06/03/2020"
    }
  ]
}