BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10064924 · Received May 18, 2020

    Report

    Report Number
    3004464228-2020-06978
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    May 4, 2020
    Report Date
    May 5, 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 RETURNED DEVICE WAS EVALUATED AND THE EXPOSED SOFT CANNULA FOR THE RECEIVED POD WAS FOUND TO BE BENT. DURING FLUID PATH TEST, THE FLUID PASSED FREELY THROUGH THE COMPLETE FLUID PATH, EVEN THOUGH THE EXPOSED SOFT CANNULA WAS KINKED. IT COULD NOT BE CONCLUSIVELY DETERMINED WHEN THIS DAMAGE TO SOFT CANNULA OCCURRED. POD DOWNLOAD DATA DID NOT INDICATE ANY PULSE WIDTH INCREASES OR SIGNS OF STRUGGLE IN INSULIN DELIVERY DURING OPERATION. AFTER INVESTIGATING THE POD, NO DAMAGE OR TEAR WAS FOUND ALONG THE COMPLETE FLUID PATH THAT WOULD CAUSE ANY LEAKAGE OF INSULIN FROM THE POD.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE,  MODEL: UST400,  17845-5A-AW REV B 09/17.  CHECKING YOUR BLOOD GLUCOSE,  CHAPTER 4 / PAGE 36:  WARNINGS:   TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA).   TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA).   IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 115), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL OR ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 270 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT A ENW POD WAS APPLIED AND A CORRECTION BOLUS WAS ADMINISTERED. THE PATIENT'S BLOOD GLUCOSE HISTORY ARE AS FOLLOWS: TIME: 12:00 PM, BG(MG/DL): 140; 2:00 PM, 270-280; 6:00 PM, >250.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531746 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45280 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR