BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 8864100 · Received August 6, 2019

    Report

    Report Number
    3004464228-2019-07213
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 16, 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 · 1

    THE POD WAS RECEIVED WITH THE SOFT CANNULA DEPLOYED AND THE FORMED NEEDLE VISIBLE THROUGH THE SOFT CANNULA. AFTER OPENING THE POD, THE NEEDLE DID FULLY RETRACT. EVIDENCE OF A LINKAGE ASSEMBLY ERROR IS SUPPORTED BY MARKINGS FOUND ON THE INSIDE OF THE TOP HOUSING AND THE LINKAGE ASSEMBLY SLIGHTLY ELEVATED OUT OF THE SLIDE RETRACT. THE EXACT CAUSE OF THE NEEDLE FAILING TO FULLY RETRACT COULD NOT BE CONCLUSIVELY DETERMINED. IN ADDITION, THE SOFT CANNULA WAS BENT AND RIPPED AT THE TIP OF THE FORMED NEEDLE. IT COULD NOT BE CONCLUSIVELY DETERMINED WHEN THESE DAMAGES OCCURRED AND IF THIS AFFECTED THE DEVICE'S ABILITY TO DELIVER INSULIN WHEN THE POD WAS WORN.

    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 THAT THE PATIENT'S BLOOD GLUCOSE LEVELS EXCEEDED 250 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 NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661440 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44609 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR