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"distributor_address_2": "",
"manufacturer_postal_code": "",
"single_use_flag": "Y",
"manufacturer_country": "",
"mdr_text": [
{
"mdr_text_key": "286332204",
"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 CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE."
},
{
"mdr_text_key": "286332205",
"text_type_code": "Description of Event or Problem",
"patient_sequence_number": "0",
"text": "IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 400 MG\/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A PEN CORRECTION WAS ADMINISTERED AND A NEW POD WAS APPLIED."
}
],
"number_patients_in_event": "",
"distributor_name": "",
"manufacturer_g1_address_1": "100 NAGOG PARK",
"distributor_zip_code": "",
"manufacturer_contact_postal_code": "01720",
"manufacturer_contact_exchange": "978",
"manufacturer_contact_pcountry": ""
},
{
"manufacturer_contact_zip_ext": "",
"manufacturer_g1_address_2": "",
"event_location": "",
"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",
"event_type": "Injury",
"report_number": "3004464228-2022-03518",
"type_of_report": [
"Initial submission"
],
"product_problem_flag": "N",
"date_received": "20220301",
"manufacturer_address_2": "",
"pma_pmn_number": "K192659",
"date_of_event": "20220228",
"reprocessed_and_reused_flag": "",
"manufacturer_address_1": "",
"exemption_number": "",
"manufacturer_contact_zip_code": "01720",
"reporter_occupation_code": "OTHER",
"manufacturer_contact_plocal": "9786007000",
"noe_summarized": "1",
"manufacturer_contact_l_name": "SPEARS",
"source_type": [
"Foreign",
"Consumer"
],
"distributor_zip_code_ext": "",
"manufacturer_g1_postal_code": "01720",
"manufacturer_g1_state": "MA",
"reporter_country_code": "US",
"manufacturer_contact_area_code": "978",
"date_added": "20220301",
"manufacturer_contact_f_name": "MICHAEL",
"previous_use_code": "I",
"device": [
{
"device_event_key": "",
"implant_flag": "",
"date_removed_flag": "",
"device_sequence_number": "1",
"date_received": "20220301",
"brand_name": "OMNIPOD DASH\u00bf 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",
"model_number": "18320",
"catalog_number": "BLE-I1-529",
"lot_number": "",
"other_id_number": "",
"device_availability": "No",
"device_report_product_code": "LZG",
"device_age_text": "",
"device_evaluated_by_manufacturer": "R",
"combination_product_flag": "N",
"udi_di": "20385082000020",
"udi_public": "(01)20385082000020",
"openfda": {
"device_name": "Pump, Infusion, Insulin",
"medical_specialty_description": "General Hospital",
"regulation_number": "880.5725",
"device_class": "2"
}
}
],
"product_problems": [
"Insufficient Information"
],
"manufacturer_zip_code": "",
"manufacturer_contact_country": "US",
"date_changed": "20220311",
"health_professional": "",
"summary_report_flag": "N",
"manufacturer_g1_zip_code_ext": "",
"manufacturer_contact_extension": "",
"manufacturer_city": "",
"manufacturer_contact_phone_number": "9786",
"patient": [
{
"patient_sequence_number": "1",
"date_received": "20220301",
"sequence_number_treatment": [
""
],
"sequence_number_outcome": [
""
],
"patient_age": "",
"patient_sex": "Male",
"patient_weight": "",
"patient_ethnicity": "",
"patient_race": "",
"patient_problems": [
"Hypersensitivity\/Allergic reaction"
]
}
],
"distributor_city": "",
"date_report": "20220228",
"initial_report_to_fda": "",
"distributor_state": "",
"event_key": "",
"manufacturer_g1_country": "US",
"manufacturer_contact_city": "ACTON",
"mdr_report_key": "13634222",
"removal_correction_number": "",
"number_devices_in_event": "",
"date_manufacturer_received": "20220228",
"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": "Y",
"distributor_address_1": "",
"manufacturer_state": "",
"distributor_address_2": "",
"manufacturer_postal_code": "",
"single_use_flag": "Y",
"manufacturer_country": "",
"mdr_text": [
{
"mdr_text_key": "286332414",
"text_type_code": "Additional Manufacturer Narrative",
"patient_sequence_number": "0",
"text": "ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION BY THE ADHESIVE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED."
},
{
"mdr_text_key": "286332416",
"text_type_code": "Description of Event or Problem",
"patient_sequence_number": "0",
"text": "IT WAS REPORTED THAT AFTER WEARING THE POD, THE PATIENT DEVELOPED AN ALLERGIC REACTION TO THE POD'S ADHESIVE. THE DOCTOR HAS PRESCRIBED A BARRIER SPRAY (MEDIHERMA) WHICH HAS NOT WORK ON THE AFFECTED AREA."
}
],
"number_patients_in_event": "",
"distributor_name": "",
"manufacturer_g1_address_1": "100 NAGOG PARK",
"distributor_zip_code": "",
"manufacturer_contact_postal_code": "01720",
"manufacturer_contact_exchange": "978",
"manufacturer_contact_pcountry": ""
}
]
}
Newly Diagnosed Type 1 Diabetics
Recommendations for Recently Diagnosed Type 1 Diabetics
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