{
  "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": {
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "N",
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      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Death",
      "report_number": "2017183-2008-00002",
      "type_of_report": [
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      ],
      "product_problem_flag": "N",
      "date_received": "20080222",
      "manufacturer_address_2": "",
      "pma_pmn_number": "033234",
      "date_of_event": "20071224",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
      "source_type": [
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        "User facility"
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "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": "20080222",
          "brand_name": "IMMULITE 2500",
          "generic_name": "IMMUNOASSAY SYSTEM",
          "manufacturer_d_name": "SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS",
          "manufacturer_d_address_1": "62 FLANDERS-BARTLEY RD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "FLANDERS",
          "manufacturer_d_state": "NJ",
          "manufacturer_d_zip_code": "07836",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "07836",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "IMMULITE 2500",
          "catalog_number": "NA",
          "lot_number": "NA",
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          "device_availability": "Yes",
          "device_report_product_code": "JJQ",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Colorimeter, Photometer, Spectrophotometer For Clinical Use",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.2300",
            "device_class": "1"
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        }
      ],
      "product_problems": [
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
      "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": "20080222",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Death"
          ],
          "patient_age": "70 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Death"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080110",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1002976",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080110",
      "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": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "796515",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "PT SERUM SAMPLE WAS RUN ON THE IMMULITE 2500 TROPONIN AND GAVE A RESULT OF 16.8. THEY, LAB RETESTED THE SAMPLE BY RE-SPINNING IT AND DISPENSING SOME INTO A HANGING CUP AND PLACING IT BACK ON THE INSTRUMENT FOR RE-TESTING. WHEN THIS SAMPLE WAS REPEATED, THE RESULT WAS <0.2. BOTH RESULTS WERE REPORTED TO THE CLINICIAN. THE PT WAS RELEASED AND LATER PASSED AWAY. AFTER THE PT EXPIRED, THE HOSP RETESTED THE SAMPLE WITH THE FOLLOWING RESULTS: 11.7 AND 12.1."
        },
        {
          "mdr_text_key": "8094528",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "INVESTIGATION HAS SHOWN THAT THE CUSTOMER IMPROPERLY USED HANGING CUPS, IN VIOLATION OF THE USER MANUAL. THE USER MANUAL IS QUITE CLEAR IN SAYING WHICH SIZE OF PRIMARY AND SECONDARY TUBES SHOULD BE USED. THE DEVICE WAS INSPECTED BY THE FIELD SERVICE ENGINEER (FSE) AND THEY FOUND NO ISSUES THAT WOULD CONTRIBUTE TO THIS INCIDENT."
        }
      ],
      "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": ""
    }
  ]
}