BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4202253 · Received October 15, 2014

    Report

    Report Number
    3004464228-2014-01545
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE CUSTOMER'S INFUSION SITE INFECTION. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POD WAS ACTIVATED ON (B)(6) 2014. THE POD WAS REMOVED ON (B)(6) 2014 AND DURING THAT TIME HIS BLOOD GLUCOSE RANGED FROM 58 MG/DL TO 384 MG/DL. THE POD WAS REMOVED BECAUSE THE CUSTOMER WAS FEELING PAIN AT THE INSERTION SITE. A DAY AND A HALF AFTER THE POD WAS REMOVED THE CUSTOMER NOTICED THAT THE INSERTION SITE HAD BECOME INFECTED. THE SITE WAS BLACK, ITCHY, WITH A BURNING SENSATION, AND HAD BEEN BLEEDING AND DISCHARGING PUSS. ON (B)(6) 2014, THE CUSTOMER WENT TO HIS DOCTOR WHO RECOMMENDED THE CUSTOMER TO A SURGEON. THE CUSTOMER WAS DIAGNOSED WITH A MAJOR SERIOUS INFECTION, AND WAS PRESCRIBED ANTIBIOTICS. THE SITE WAS CUT OPEN, AND CLEANED OUT. THE CUSTOMER WAS ADVISED TO CLEAN THE SITE DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654031 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41191

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization