BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 7752243 · Received August 6, 2018

    Report

    Report Number
    3004464228-2018-04943
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 8, 2018
    Report Date
    July 11, 2018
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K162296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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. NO LOT RELEASE RECORDS WERE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: ENT450. 17845-5C-AW REV A 10/17. CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36. WARNINGS: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNINGS: IF YOU GET RESULTS BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 117), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED HER DAUGHTER'S BLOOD GLUCOSE AND CARBOHYDRATE INTAKE HISTORY IS AS FOLLOWS: TIME BG (MMOL/L) (MG/DL) CHO (G) (B)(6). THE POD WAS DEACTIVATED AND SHE NOTICED THE CANNULA WAS BENT. THE POD WAS WORN LONGER THAN 48 HOURS. HYPERGLYCEMIA TREATED BY PATIENT ACTIVATING NEW POD AND BOLUS. TIME BG (MMOL/L) (MG/DL) CHO (G) (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595500 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR