{ "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": 253163 } }, "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": "3004464228-2020-05933", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K192659", "date_of_event": "20190615", "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": [ "CONSUMER", "FOREIGN" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "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": "466773", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "OMNIPOD INSULIN MANAGEMENT SYSTEM", "generic_name": "PUMP, INFUSION, INSULIN", "manufacturer_d_name": "INSULET CORPORATION", "manufacturer_d_address_1": "100 NAGOG PARK", "manufacturer_d_address_2": "", "manufacturer_d_city": "ACTON", "manufacturer_d_state": "MA", "manufacturer_d_zip_code": "01720", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "01720", "device_operator": "LAY USER/PATIENT", "expiration_date_of_device": "20200425", "model_number": "19191", "catalog_number": "ZXP425", "lot_number": "L44311", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200401", "device_report_product_code": "LZG", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "20385081120033", "udi_public": "(01)20385081120033(11)181025(17)200425(10)L44311", "openfda": { "device_name": "Pump, Infusion, Insulin", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250728", "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": [ "Hyperglycemia", "Hyperglycemia" ] } ], "distributor_city": "", "date_report": "20190918", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000151", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200413", "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": "204993863", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED. INSPECTION OF THE CANNULA ASSEMBLY FOUND THAT THE EXPOSED PORTION OF THE SOFT CANNULA WAS STRETCHED AND LEAKED AT THE FORMED NEEDLE TIP. UPON MAGNIFICATION, THE FORMED NEEDLE COULD BE SEEN POKING THROUGH THE SOFT CANNULA. FLUID COULD NOT FLOW PAST THE STRETCHED PORTION OF THE SOFT CANNULA. IT COULD NOT BE DETERMINED WHEN THIS DAMAGE OCCURRED AND IT COULD NOT BE CONCLUSIVELY DETERMINED IF THIS AFFECTED THE DEVICE¿S ABILITY TO DELIVER INSULIN WHEN THE POD WAS WORN. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: ENT450, 17845-5C-AW REV A 10/17. CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36: WARNING: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNING: IF YOU GET RESULTS BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE \"LIVING WITH DIABETES\" ON PAGE 117), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." }, { "mdr_text_key": "204993864", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THE PATIENTS BLOOD GLUCOSE LEVEL ROSE TO 366 MG/DL AFTER WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE ARM." } ], "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": "" } ] }