BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 10179618 · Received June 22, 2020

    Report

    Report Number
    3004464228-2020-09620
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    June 13, 2020
    Report Date
    June 13, 2020
    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

    INVESTIGATION CONFIRMED A KINK IN THE EXPOSED PORTION OF THE SOFT CANNULA. AFTER THE TOP HOUSING WAS REMOVED, A TEAR WAS FOUND WHERE THE KINK OCCURRED AND FLUID WAS SEEN EXITING THE SITE OF TEAR. IT CANNOT BE CONFIRMED WHEN DAMAGES TO THE CANNULA OCCURRED OR WHAT CAUSED THE DAMAGES. THEREFORE, IT CANNOT BE CONFIRMED IF THIS CONTRIBUTED TO LEAKING DURING WEAR.CORRECTION TO D(4): SEQUENCE NUMBER CHANGED FROM 115004 TO 1150004. UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4) TO (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF 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. OMNIPOD DASH INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: 18320. 18296-ENG-AW REV B 06/18. BLOOD GLUCOSE READINGS. CHAPTER 4 / PAGE 56. WARNINGS: BLOOD GLUCOSE READINGS BELOW 70 MG/DL MAY INDICATE HYPOGLYCEMIA (LOW BLOOD GLUCOSE). BLOOD GLUCOSE READINGS ABOVE 250 MG/DL MAY INDICATE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). FOLLOW YOUR HEALTHCARE PROVIDER'S SUGGESTIONS FOR TREATMENT. FOR YOUR REFERENCE, INSULET MODIFIED OUR INTERNAL INVESTIGATION FINDING CODES EFFECTIVE 25 MAY 2020 AS PART OF AN EFFORT TO IMPROVE THE CLASSIFICATION OF FINDINGS TO IMPROVE THE POWER OF TRENDING DATA AND MAKE THE FINDINGS MORE INTUITIVE. THE NEW FINDINGS CODES WILL USE THE SYSTEM OF FINDING CATEGORY (E.G. HARDWARE COMPONENT), FOLLOWED BY THE AFFECTED COMPONENT (E.G. NEEDLE), FOLLOWED BY THE CONDITION (E.G. BENT). THEREFORE YOU MAY NOTICE FINDINGS THAT APPEAR TO BE NEW OR DIFFERENT BUT IN FACT ARE JUST RENAMED FOR IMPROVED DATA VALUE. INSULET WOULD BE HAPPY TO EXPLAIN ANY MAPPING OF THE OLD TO NEW FINDING CODES IF YOU HAVE ANY QUESTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 304 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT/KINKED, WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643181 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C12131951 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR