BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3952062 · Received July 17, 2014

    Report

    Report Number
    3004464228-2014-01012
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED DAMAGE CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE PATIENT'S INFECTION AND HYPERGLYCEMIA. QUALIFICATION AND STERILIZATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2014, SHE ACTIVATED A NEW POD ON HER BACK AND HER BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY IS AS FOLLOWS: SHE STATED THAT HER SITE IS NOW SWOLLEN, RED AND THAT THE CANNULA WAS(B)(6) 2014, SHE WENT TO HER DOCTOR WHO CONFIRMED THAT THERE WAS 3 PIECES BROKEN INTO HER SKIN. THEY HAD TO NUMB THE AREA WITH NOVOCAIN, USED TWEEZERS AND A SCALPEL TO REMOVE THE FOREIGN OBJECT OUT OF HER SKIN. THEY ALSO PLACED HER ON A 10 DAY TREATMENT OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420305 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000ZXP425 05/01/2015

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other