{
  "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": "2026-09-29",
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "MA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "ACTON",
      "manufacturer_contact_address_1": "100 NAGOG PARK",
      "manufacturer_contact_pcity": "97860070",
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      "report_number": "3014585508-2026-32303",
      "type_of_report": [
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      "pma_pmn_number": "K231826",
      "date_of_event": "20260507",
      "reprocessed_and_reused_flag": "N",
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      "reporter_occupation_code": "OTHER",
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      "manufacturer_contact_l_name": "HEYL",
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      "manufacturer_contact_area_code": "",
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          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260603",
          "brand_name": "OMNIPOD 5 PODS",
          "generic_name": "OMNIPOD 5 PODS",
          "manufacturer_d_name": "INSULET CORPORATION",
          "manufacturer_d_address_1": "100 NAGOG PARK",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "ACTON",
          "manufacturer_d_state": "MA",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
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          "device_operator": "LAY USER/PATIENT",
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          "lot_number": "PR1U01142631",
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          "device_availability": "No",
          "device_report_product_code": "QFG",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "*",
          "combination_product_flag": "N",
          "udi_di": "20385083000579",
          "udi_public": "(01)20385083000579(11)260114(17)280114(10)PR1U01142631",
          "openfda": {
            "device_name": "Alternate Controller Enabled Insulin Infusion Pump",
            "medical_specialty_description": "Clinical Chemistry",
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          }
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      ],
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      ],
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260618",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "date_received": "20260603",
          "sequence_number_treatment": [
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Hyperglycemia"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260602",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "ACTON",
      "mdr_report_key": "25369282",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260507",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "01720",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "INSULET CORPORATION",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "Y",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "404480949",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 256 MG/DL WHILE WEARING THE POD. WHEN THE POD WAS REMOVED FROM THE INFUSION SITE, THE POD'S CANNULA WAS FOUND BENT. NO TREATMENT WAS REPORTED."
        },
        {
          "mdr_text_key": "404480950",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_IOS. OMNIPOD SOFTWARE APP VERSION: 2.1.0. OPERATING SYSTEM: 26.4. HARDWARE: IPHONE14.6. CGM SENSOR TYPE: G7. PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "100 NAGOG PARK",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "01720",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}