{
  "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": "2026-06-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 65
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "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": "3003673482-2013-00028",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20131209",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K082562",
      "date_of_event": "20121001",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "NOT APPLICABLE",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "Consumer",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20140325",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "639161",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20131209",
          "brand_name": "APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR",
          "generic_name": "NSU 862-2570",
          "manufacturer_d_name": "LIFE TECHNOLOGIES HOLDINGS PTE. LTD.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SINGAPORE",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "SN",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "4407205",
          "lot_number": "275030111",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NSU",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Instrumentation For Clinical Multiplex Test Systems",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.2570",
            "device_class": "2"
          }
        }
      ],
      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250813",
      "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": "20131209",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": ""
        }
      ],
      "distributor_city": "",
      "date_report": "20121002",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3613335",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20121002",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "Repair"
      ],
      "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": "11517965",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH THE SDS SOFTWARE VERSION 1.4 IS A REAL-TIME NUCLEIC ACID AMPLIFICATION AND DETECTION SYSTEM THAT MEASURE NUCLEIC ACID SIGNALS FROM REVERSE TRANSCRIBED RNA AND CONVERTS THEM TO COMPARATIVE QUANTITATIVE READOUTS USING FLUORESCENT DETECTION OF DUAL-LABELED HYDROLYSIS PROBES. THE 7500 FAST DX REAL-TIME PCR INSTRUMENT IS TO BE USED ONLY BY TECHNOLOGISTS TRAINED IN LABORATORY TECHNIQUES, PROCEDURES, AND ON USE OF THE ANALYZER. THE INVESTIGATION FOUND THAT THE PROBLEM WAS DUE TO POWER ISSUES. THE INSTRUMENT WAS REPAIRED BY REPLACING THE POWER SUPPLY, POWER AMPLIFIER, LAMP HOLDER, LAMP POWER CORD AND ADVISED CUSTOMER TO ADD UNINTERRUPTIBLE POWER SUPPLY (UPS). THIS IS THE INITIAL AND FINAL REPORT FOR THIS ISSUE."
        },
        {
          "mdr_text_key": "4156150",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "A CUSTOMER REPORTED THAT THE INSTRUMENT APPLIED BIOSYSTEMS 7500 FAST DX (CAT. NO. 4407205) WITH SERIAL NO. (B)(4) HAD POOR AMPLIFICATION CURVES, DIP. NO PT INVOLVEMENT REPORTED."
        }
      ],
      "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": ""
    }
  ]
}