BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 11877750 · Received May 25, 2021

    Report

    Report Number
    3004464228-2021-08026
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 11, 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

    NO DAMAGES WERE OBSERVED WITH THE EXPOSED PORTION OF THE SOFT CANNULA DURING INVESTIGATION. FLUID WAS OBSERVED PASSING THROUGH THE FLUID PATH SUCCESSFULLY AND EXITING THROUGH THE DISTAL TIP OF THE SOFT CANNULA. THE DATA DOWNLOADED FROM THE DEVICE DID NOT SHOW ANY TIMEOUTS OR DRIVE STALLS DURING THE RUN. NO OTHER DAMAGES OR DEFECTS NOTED DURING THE INVESTIGATION.

    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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 323 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 MANUAL BOLUS INJECTION OF INSULIN (10U) WAS DELIVERED AND A NEW POD WAS APPLIED. THEN 3 UNITS WAS DELIVERED WITH THE NEW POD. THE PATIENT'S BLOOD GLUCOSE, CARBOHYDRATE, AND INSULIN HISTORY ARE AS FOLLOWS: TIME, BG(MG/DL), CHO(G), BOLUS(U). (B)(6) 2021. 9:55P, BG 130-142, NO CARBS, NO BOLUS. 11:15P, BG 176 NO CARBS, NO BOLUS. (B)(6). 2:02A, BG 193, BOLUS 5/UNITS. 3:28A, BG 184, FALLING SLIGHTLY, CARBS 20. 4:21A, BG 323, BOLUS WITH PEN OF 10/UNITS. 9:06A, BG 296, CUSTOMER GIVING BOLUS WITH PEN. CUSTOMER KEPT GIVING HIMSELF BOLUS WITH PEN AND NOT THE POD. I ENCOURAGE CUSTOMER IN FUTURE TO GIVE BOLUSES WITH THE POD TO SEE IF THE POD IS WORKING. IF HIS BG IS OVER 250 AND HE HAS TRIED 2-3 TIMES AND THE BG CONTINUE TO RISE, SOMETHING IS WRONG AND WE WILL REPLACE THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775951 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C09182031 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR