BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 18719728 · Received February 16, 2024

    Report

    Report Number
    3004464228-2024-05651
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    February 16, 2024
    Report Date
    February 20, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K211575
    Adverse Event
    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 AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    SECTION B2: OUTCOMES ATTRIBUTED TO AE CHANGED FROM: OTHER SERIOUS TO: OTHER SERIOUS AND REQUIRED INTERVENTION. SECTION B5:DESCRIBE EVENT OR PROBLEM ADDITIONAL INFORMATION ADDED. SECTION H6: ADVERSE EVENT PROBLEM HEALTH EFFECT - CLINICAL CODE ADDED CODES E231501 AND E172001. SECTION H6: ADVERSE EVENT PROBLEM HEALTH EFFECT - IMPACT CODE CHANGED FROM F11 TO F12.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SKIN IRRITATION CAUSING EXCESSIVE INFLAMMATION, PAIN AND SWELLING HAD OCCURRED WHILE WEARING THE POD ON THE ARM FOR BETWEEN 37 AND 48 HOURS. THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS ROSE TO 22 MMOL/L (396 MG/DL). THE PATIENT VISITED HER DOCTOR AND WAS PRESCRIBED ANTIBIOTICS FOR TREATMENT. A NEW POD WAS APPLIED TO TREAT THE BG LEVELS. THE POD WAS DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SKIN IRRITATION CAUSING EXCESSIVE INFLAMMATION, PAIN AND SWELLING HAD OCCURRED WHILE WEARING THE POD ON THE ARM FOR BETWEEN 37 AND 48 HOURS. THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS ROSE TO 22 MMOL/L (396 MG/DL). THE PATIENT VISITED HER GENERAL PRACTITIONER (GP) AND HAD THE ABSCESS LANCED AND PURULENT DISCHARGE DRAINED. THE PATIENT WAS ALSO PRESCRIBED FLUCLOXACILLIN ANTIBIOTICS (TAKE FOR TEN-TWELVE DAYS) FOR TREATMENT. A NEW POD WAS APPLIED TO TREAT THE BG LEVELS. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426857 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention