BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 12094267 · Received June 30, 2021

    Report

    Report Number
    3004464228-2021-10511
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 23, 2021
    Report Date
    June 23, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INSERTION SITE AFTER WEARING THE POD. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND DIAGNOSED WITH CELLULITIS. PATIENT REPORTED PAIN IRRITATION, DRAINAGE AND AN ABSCESS. THE PATIENT WAS DIAGNOSED WITH CELLULITIS AND PROVIDED A TOPIC ANTIBIOTIC AND OIL. PATIENT WAS PRESCRIBED BACTRIM, TO BE TAKEN TWICE DAILY FOR 6 DAYS; AND MUPIROCIN (2%), TO BE USED EVERY 4 TO 6 HOURS. THE FOLLOWING FIELDS WERE ALSO UPDATED BASED ON THE ADDITIONAL INFORMATION PROVIDED: B1 - ADVERSE EVENT/PRODUCT PROBLEM : ADVERSE EVENT. B2 - OUTCOMES ATTRIBUTED TO AE: REQUIRED INTERVENTION. H1 - TYPE OF REPORTABLE EVENT: SERIOUS INJURY. H6 - ADVERSE EVENT PROBLEM: HEALTH EFFECT - CLINICAL CODE: E1719 SKIN INFECTION/E1720 SKIN INFLAMMATION/IRRITATION/E2330 PAIN/E231501 PURULENT DISCHARGE/E17002 CELLULITIS. HEALTH EFFECT - IMPACT CODE: F11 MINOR INJURY/ILLNESS/IMPAIRMENT.

    Additional Manufacturer Narrative · 1

    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. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 500 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, MANUAL INJECTIONS OF INSULIN WERE DELIVERED. THE PATIENT'S BLOOD GLUCOSE HISTORY IS AS FOLLOWS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993715 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention