BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 11339492 · Received February 17, 2021

    Report

    Report Number
    3004464228-2021-02380
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    December 17, 2020
    Report Date
    December 18, 2020
    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 · 1

    INSPECTION OF THE CANNULA ASSEMBLY FOUND NO PROBLEMS WITH FLUID PASSING FREELY THROUGH THE COMPLETE FLUID PATH, THOUGH THE EXPOSED PORTION OF THE SOFT CANNULA WAS KINKED. IT COULD NOT BE DETERMINED WHEN THIS DAMAGE OCCURRED. THE DOWNLOAD DATA DOES NOT CONTAIN ANY TIMEOUTS THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN. NO OTHER DAMAGES OR MANUFACTURING DEFICIENCIES WERE FOUND THAT WOULD RESULT IN THE DEVICE FAILING TO DELIVER INSULIN. INSPECTION OF THE DRIVE MECHANISM COMPONENTS FOUND THE TUBE NUT IN CONTACT WITH THE RESERVOIR CAP, INCREASING THE RESISTANCE OF THE RATCHET GEAR ROTATING. THIS MISALIGNMENT OF THE TUBE NUT DID NOT PREVENT THE DEVICE FROM DELIVERING INSULIN. AFTER INVESTIGATION, NO DAMAGES, TEARS, OR LEAKS WERE FOUND IN THE FLUID PATH THAT WOULD RESULT IN FLUID LEAKING FROM THE POD. THE POD WAS RECEIVED WITH EVIDENCE OF BLOOD ON THE ADHESIVE PAD. INVESTIGATION RESULTS FOUND NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD CAUSE BLEEDING OR BRUISING AT THE INFUSION SITE. THE EXACT CAUSE OF THE REPORTED BLEEDING AND BRUISING COULD NOT BE DETERMINED. 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 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 GREATER THAN 250 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS ON THE INFUSION SITE (HIP/BUTTOCKS). THE POD LEAKING INSULIN DURING WEAR AND BLEEDING AT THE INFUSION SITE WERE ALSO REPORTED. AS TREATMENT, THE POD WAS REMOVED, A NEW POD WAS APPLIED, AND A BOLUS WAS ADMINISTERED WITH AN INSULIN PEN. THE PATIENT'S BLOOD GLUCOSE HISTORY IS AS FOLLOWS: TIME BG(MG/DL), BEFORE INCIDENT 143, 146, INCIDENT AROUND OR GREATER THAN 250. AFTER INCIDENT 142, 106.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234773 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L72089 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1