{
  "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": 1708607
    }
  },
  "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": "2032227-2020-110194",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200427",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20200422",
      "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": [
        "COMPANY REPRESENTATIVE",
        "FOREIG"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "IN",
      "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": "465223",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200427",
          "brand_name": "PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWL",
          "generic_name": "PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR",
          "manufacturer_d_name": "MEDTRONIC PUERTO RICO OPERATIONS CO.",
          "manufacturer_d_address_1": "CEIBA NORTE IND. PARK #50 ROAD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "JUNCOS",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "00777",
          "manufacturer_d_zip_code_ext": "-386",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "00777-3869",
          "device_operator": "LAY USER/PATIENT",
          "model_number": "MMT-754WWL",
          "catalog_number": "MMT-754WWL",
          "lot_number": "B5754WWLJ",
          "other_id_number": "",
          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20201119",
          "device_report_product_code": "OYC",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00643169507661",
          "udi_public": "(01)00643169507661",
          "openfda": {
            "registration_number": [
              "2032227"
            ],
            "fei_number": [
              "3003166194"
            ],
            "device_name": "Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        }
      ],
      "product_problems": [
        "Mechanical Problem",
        "Mechanical Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "12/04/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250812",
      "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": "20201206",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000039",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200422",
      "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": "192395952",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "(B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES."
        },
        {
          "mdr_text_key": "192395953",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS."
        },
        {
          "mdr_text_key": "231199705",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "DEVICE PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST. NO MOTOR ERROR ALARM NOTED DURING TEST. MOTOR PASSED MOTOR TEST. (B)(4)."
        }
      ],
      "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": "12/06/2020"
    }
  ]
}