BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10691155 · Received October 16, 2020

    Report

    Report Number
    3004464228-2020-16357
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    October 4, 2020
    Report Date
    October 6, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    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 DEPLOYED. NO BENDS OR KINKS WERE OBSERVED IN THE EXPOSED PORTION OF THE SOFT CANNULA. FLUID WAS ABLE TO FLOW THROUGH THE FLUID PATH WITH NO SIGNS OF STRUGGLE. NO OTHER DEFECTS OR DEFICIENCIES WERE FOUND THAT WOULD RESULT IN A FAILURE OF THE DEVICE TO DELIVER INSULIN.

    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 HIGH, OVER 500 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (BACK), THE POD'S CANNULA WAS FOUND BENT IN HALF. AS TREATMENT FOR HYPERGLYCEMIA, SEVERAL BOLUSES WERE DELIVERED, AND A NEW POD WAS APPLIED. THEN A MANUAL INJECTION OF INSULIN WAS GIVEN. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY ARE AS FOLLOWS: BG(MG/DL): BOLUS(U): ON (B)(6) 2020, 354 MG/DL; GAVE A BOLUS BEFORE THE HOCKEY GAME, BUT DOES NOT RECALL THE AMOUNT. (B)(6) 2020 - 240S MG/DL RANGE - DURING THE GAME. (B)(6) 2020- 2:00 PM - HIGH - REPLACED THE POD, AND GAVE A MANUAL SHOT OF 6 UNITS OF INSULIN. (B)(6) 2020- STAYED ABOVE 200 MG/DL ALL DURING THE NIGHT. (B)(6) 2020 - STAYED ABOVE 250 MG/DL ALL DURING THE DAY. (B)(6) 2020 - 2:00 PM - GAVE A BOLUS BUT DOES NOT RECALL THE BOLUS AMOUNT. (B)(6) 2020 - 124 MG/DL - AFTER GETTING OFF THE ICE FROM HOCKEY PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157590 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45864 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR