BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 14497398 · Received May 25, 2022

    Report

    Report Number
    3004464228-2022-08588
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 24, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 HOSPITALIZATION AND DIABETIC KETOACIDOSIS. 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Additional Manufacturer Narrative · 0

    FROM: IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 20.2 MMOL/L (363.6 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. THE PATIENT WAS TREATED WITH MANUAL INSULIN INJECTIONS AND LEVEMIR INSULIN. THE PATIENT WAS RELEASED AFTER 3 DAYS. THE POD WAS REMOVED AT THE HOSPITAL. TO: IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 20.6 MMOL/L (370.8 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INSULIN INJECTION WAS ADMINISTERED AND A NEW POD WAS APPLIED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS TREATED WITH MANUAL INSULIN INJECTIONS. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER 2 DAYS. H6 - ADVERSE EVENT PROBLEM MEDICAL DEVICE PROBLEM CODE FROM A26 INSUFFICIENT INFORMATION TO A040609 MATERIAL TWISTED/BENT COMPONENT CODE FROM G04105 PUMP TO G04019 CANNULA H10 - ADDTL MFG NARRATIVE FROM: 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 HOSPITALIZATION AND DIABETIC KETOACIDOSIS. 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. TO: 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 HOSPITALIZATION AND DIABETIC KETOACIDOSIS. 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 20.2 MMOL/L (363.6 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. THE PATIENT WAS TREATED WITH MANUAL INSULIN INJECTIONS AND LEVEMIR INSULIN. THE PATIENT WAS RELEASED AFTER 3 DAYS. THE POD WAS REMOVED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723358 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1K05242121 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Hospitalization