BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 11649685 · Received April 12, 2021

    Report

    Report Number
    3004464228-2021-05350
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    April 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED. INSPECTION OF THE NEEDLE MECHANISM, ENVIRONMENTAL SEAL, BOTTOM HOUSING AND CANNULA ASSEMBLY FOUND NO ISSUES THAT WOULD RESULT IN THE CANNULA INSERTING IMPROPERLY. THE DOWNLOADED DATA SHOWS NO INCREASE IN PULSE WIDTHS OR SIGNS OF STRUGGLE DURING THE RUN THAT WOULD INDICATE A FAILURE OF THE POD TO DELIVER INSULIN. THE CAUSE OF THE REPORTED IMPROPER INSERTION COULD NOT BE CONCLUSIVELY DETERMINED. BLOOD WAS OBSERVED ON THE ADHESIVE PAD. THE CANNULA ASSEMBLY WAS CHECKED FOR MANUFACTURING DEFICIENCIES THAT COULD CONTRIBUTE TO BLEEDING OR BRUISING AND NOTHING WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 380 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. DUE TO ELEVATED BG LEVELS, PATIENT REALIZED THE CANNULA HAD NOT PROPERLY INSERTED IN THE INFUSION SITE. ADDITIONAL METHOD OF TREATMENT WAS NOT PROVIDED. THE PATIENT'S BLOOD GLUCOSE HISTORY IS AS FOLLOWS: BG(MG/DL): 151, 201, 364, 332, 380.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545073 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C08062041 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR