BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 11337698 · Received February 17, 2021

    Report

    Report Number
    3004464228-2021-02305
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    February 3, 2021
    Report Date
    February 3, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED WITH THE CANNULA ASSEMBLY FULLY DEPLOYED AND THE FORMED NEEDLE COMPLETELY RETRACTED. NO BENDS, KINKS OR DAMAGES WERE OBSERVED ON THE SOFT CANNULA. INVESTIGATION FOUND NO ABNORMALITIES WITH THE FLUID PATH AND NEEDLE MECHANISM THAT WOULD CONTRIBUTE TO THE CANNULA INSERTING IMPROPERLY. IN ADDITION, THE FORMED NEEDLE AND BOTTOM HOUSING WERE INSPECTED, AND NO ABNORMALITIES WERE FOUND THAT WOULD CONTRIBUTE TO THE REPORTED PAIN DURING INSERTION. THE CAUSE OF THE REPORTED IMPROPER INSERTION AND PAIN DURING INSERTION COULD NOT BE CONCLUSIVELY DETERMINED. NO OTHER DAMAGES OR DEFECTS WERE FOUND THAT WOULD RESULT IN A FAILURE TO DELIVER INSULIN.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. 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. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. ADDITIONALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 260, 255, 262, 320, 335, AND EVENTUALLY 353 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (ABDOMEN). PAIN AT THE INFUSION SITE WAS ALSO REPORTED. WHEN REMOVED, THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED AND A BOLUS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233711 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L71105 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1