BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 11150053 · Received January 11, 2021

    Report

    Report Number
    3004464228-2021-00360
    Event Type
    Injury
    Date Received
    January 11, 2021
    Date of Event
    January 2, 2021
    Report Date
    January 2, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED. THE CUSTOMER REPORTED THAT THE CANNULA DISLODGED FROM THE INFUSION SITE. NO DAMAGES OR DEFECTS WERE OBSERVED THAT WOULD CAUSE THE CANNULA TO DISLODGE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO ISSUES WERE OBSERVED WITH THE EXPOSED PORTION OF THE SOFT CANNULA AND FLUID WAS OBSERVED PASSING THROUGH SUCCESSFULLY. THE DATA DID NOT SHOW ANY INCREASE IN PULSE WIDTHS THAT WOULD INDICATE AN OCCLUSION FROM A BENT/KINKED CANNULA.

    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 THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE AND WAS BENT . 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 CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE A PATIENT WAS WEARING A POD FOR LONGER THAT 48 HOURS THEIR BLOOD GLUCOSE LEVEL READ HIGH (>500 MG/DL). THE PATIENT EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA, DEHYDRATION AND A RAPID HEARTBEAT. AS TREATMENT THE PATIENT ADMINISTERED MULTIPLE BOLUSES OF INSULIN FOR A TOTAL OF 14.95 UNITS OF INSULIN. UPON REMOVAL OF THE POD FROM THE INSERTION SITE THE CANNULA WAS FOUND TO BE DISLODGED AND BENT. THE PATIENT APPLIED A NEW POD. THE PATIENT CALLED 911 AND THE EMERGENCY MEDICAL TECHNICIANS (EMT) ARRIVED AT THE PATIENTS HOME. THE EMT'S CHECKED THE PATIENTS OXYGEN LEVELS (98 %), TEMPERATURE (97.2) AND BLOOD GLUCOSE LEVELS. THE PATIENT DECLINED GOING TO THE EMERGENCY ROOM. ONCE THE EMT'S HAD LEFT THE PATIENT CONTACTED HER DOCTOR OFFICE FOR ADVICE. THE PATIENT WAS GIVEN ADVICE FROM HER DOCTORS OFFICE TO WAIT AN HOUR DUE TO THE PATIENTS BLOOD GLUCOSE LEVELS WERE DECREASING AND RECOMMENDS BLOOD SUGARS OVER 500 MG/DL FOR THE PATIENT TO GO TO EMERGENCY ROOM. THE PATIENT REPORTS THEIR LAST BLOOD GLUCOSE LEVEL AT 9:13 AM WAS 200 MG/DL. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY ARE AS FOLLOWS: TIME BG(MG/DL) BOLUS(U) 1/1/2021 131 5.4 8:30 PM 328 2.5 1/2/2021 12:30 AM 428 4.25 POD DEACTIVATED 7:36 AM 252 2.8 9:13 AM 200

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45123 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C08042031 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention