BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH, PODS 10-PACK

    MDR report key: 16570542 · Received March 19, 2023

    Report

    Report Number
    3004464228-2023-07373
    Event Type
    Malfunction
    Date Received
    March 19, 2023
    Date of Event
    February 28, 2023
    Report Date
    March 11, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K211575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. 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 CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.

    Additional Manufacturer Narrative · 0

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED. THE CANNULA MEASURED THE CORRECT FULL LENGTH ACCORDING TO SPECIFICATION AND DID NOT APPEAR BENT/KINKED. INSPECTION OF THE CANNULA ASSEMBLY FOUND NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD RESULT IN THE DEVICE FAILING TO DELIVER INSULIN. DATA OBTAINED FROM THE DEVICE GENERATED AN 0X29 ALARM. THE ALARM INDICATED ALERT 0 HAD TRANSITIONED TO ALARM. ALERT 0 IS USED AS AUTO-OFF ALERT WHICH IS INTENDED TO FORCE THE USER TO COMMUNICATE WITH THE POD WITHIN A CERTAIN TIME INTERVAL SET BY THE USER. GENERATION OF THE ALARM STOPPED THE DELIVERY OF INSULIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 16 MMOL/L (288 MG/DL) WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS ON THE ABDOMEN. THE POD WAS REMOVED, AND THE CANNULA WAS NOTED TO BE BENT. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362001 OMNIPOD DASH, PODS 10-PACK PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000029 PD1K05262211

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female