{
  "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": "2026-04-28",
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      "manufacturer_contact_zip_ext": "",
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      "manufacturer_contact_t_name": "MR.",
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          "generic_name": "ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP",
          "manufacturer_d_name": "BETA BIONICS INC.",
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      "manufacturer_contact_country": "US",
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      "summary_report_flag": "N",
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          "date_received": "20260331",
          "sequence_number_treatment": [
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      "date_report": "20260330",
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      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "IRVINE",
      "mdr_report_key": "24737917",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260308",
      "manufacturer_name": "",
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      "remedial_action": [
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      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "BETA BIONICS, INC.",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
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      "single_use_flag": "N",
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      "mdr_text": [
        {
          "mdr_text_key": "397076146",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT A USER OF THE ILET REPORTED CONCERN ABOUT IMPENDING HYPOGLYCEMIA DUE TO HAVING 8 UNITS OF INSULIN ON BOARD WHILE BLOOD GLUCOSE WAS ELEVATED AROUND 292 MG/DL AND TRENDING DOWN, AND THE USER PAUSED INSULIN DELIVERY AND REQUESTED TO SPEAK WITH A CLINICIAN. SYMPTOMS INCLUDED ANXIETY ABOUT LOW BLOOD GLUCOSE. OUTCOMES INCLUDED NO REPORTED INJURY, HOSPITALIZATION, OR ALARMS. INVESTIGATION INCLUDED TROUBLESHOOTING AND USER EDUCATION WITH ASSIGNMENT FOR ADDITIONAL TRAINING. INVESTIGATION OF THIS CASE REVEALED NO DEVICE ALARMS AND NO CONFIRMED DEVICE MALFUNCTION. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS UNCLEAR. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "11 HUGHES",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "92618",
      "manufacturer_contact_exchange": "949",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}