{ "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": "2026-06-16", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "IRVINE", "manufacturer_contact_address_1": "11 HUGHES", "manufacturer_contact_pcity": "94928883", "event_type": "Malfunction", "report_number": "3019004087-2026-44876", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260430", "manufacturer_address_2": "", "pma_pmn_number": "K231485", "date_of_event": "20260326", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92618", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9492888350", "noe_summarized": "1", "manufacturer_contact_l_name": "FUKUSHIMA", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "92618", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "949", "date_added": "20260430", "manufacturer_contact_f_name": "JARED", "device_date_of_manufacturer": "20250331", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "396367", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260430", "brand_name": "ILET BIONIC PANCREAS", "generic_name": "ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP", "manufacturer_d_name": "BETA BIONICS, INC.", "manufacturer_d_address_1": "11 HUGHES", "manufacturer_d_address_2": "", "manufacturer_d_city": "IRVINE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92618", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92618", "device_operator": "LAY USER/PATIENT", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "QFG", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Alternate Controller Enabled Insulin Infusion Pump", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "880.5730", "device_class": "2" } } ], "product_problems": [ "Unexpected Shutdown" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260514", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9492", "patient": [ { "patient_sequence_number": "1", "date_received": "20260430", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "53 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hyperglycemia", "Urinary Frequency / Polyuria" ] } ], "distributor_city": "", "date_report": "20260429", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "IRVINE", "mdr_report_key": "25038623", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92618", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BETA BIONICS, INC.", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "400629483", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INITIAL." }, { "mdr_text_key": "400629484", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE ILET COULD NOT COMPLETE THE REWIND PROCESS DURING A SUPPLY CHANGE, THE PISTON DID NOT ADVANCE IN THE CHAMBER DESPITE RESTARTS AND DRY-RUN ATTEMPTS, THE DEVICE BECAME UNAVAILABLE FOR USE, AND A REPLACEMENT DEVICE WAS SENT; THE USER HAS BEEN BOLUSING FOR MEALS ONLY AND USING SUBCUTANEOUS INSULIN VIA PEN AS BACKUP. 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