BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 9470590 · Received December 14, 2019

    Report

    Report Number
    3004464228-2019-12935
    Event Type
    Malfunction
    Date Received
    December 14, 2019
    Date of Event
    November 21, 2019
    Report Date
    November 21, 2019
    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 · 0

    THE RETURNED DEVICE WAS EVALUATED AND NO ISSUES 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. NO OTHER DAMAGES OR DEFECTS WERE FOUND THAT WOULD RESULT IN A FAILURE OF THE DEVICE TO DELIVER INSULIN.D4 - SERIAL NO CHANGED FROM 10500521 TO 1050521. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM(B)(4). TO (B)(4).

    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: ENT450, 17845-5C-AW REV A 10/17. CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36: WARNING: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNING: 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

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 19 MMOL/L (342 MG/DL) WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS ON THE ABDOMEN. THE PATIENT COULD SMELL AND FEEL INSULIN LEAKING OUT. THE POD WAS REMOVED AND THE CANNULA WAS NOTED TO BE BENT. HYPERGLYCEMIA TREATED BY ACTIVATING A NEW POD AND BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265135 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44648 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR