BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8437732 · Received March 20, 2019

    Report

    Report Number
    3004464228-2019-02236
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    February 25, 2019
    Report Date
    February 25, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND NO KINKS OR BENDS WERE IDENTIFIED ON THE EXPOSED PORTION OF THE CANNULA. FLUID PATH TESTING SHOWED THAT INSULIN WAS ABLE TO PASS OUT THE DISTAL TIP OF THE SOFT CANNULA. NO OTHER DEFECTS OR DEFICIENCIES WERE IDENTIFIED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED BENT CANNULA OR TO DETERMINE WHETHER IT 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: CAT45E/CAT45F. 15546-AW REV D 06/2016. CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 98. 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 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 THE PATIENT¿S BLOOD GLUCOSE REACHED BETWEEN 14, 19 TO 20 MMOL/L (252, 342 TO 360 MG/DL) AND THAT THE CANNULA WAS BENT. HYPERGLYCEMIA TREATED BY PATIENT WITH A CORRECTION BOLUS AND ACTIVATING NEW POD. INSULIN WAS LEAKING AT THE INSERTION SITE AND THAT THE ADHESIVE PAD WAS WET. THE POD WAS WORN BETWEEN 36 AND 48 HOURS ON THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229412 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L44200

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR