BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3854864 · Received May 20, 2014

    Report

    Report Number
    3004464228-2014-00686
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 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 WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO ASSESS IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S INFECTION. NO QUALIFICATION AND STERILIZATION RECORDS WERE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AFTER WEARING THE POD ON HER ARM FOR LESS THAN A DAY; HER ARM STATED TO SWELL UP AND HER BLOOD GLUCOSE WAS ALSO RISING (EXACT BG LEVEL WAS NOT PROVIDED). SHE WENT TO SEE HER DOCTOR WHO PRESCRIBED HER WITH ANTIBIOTICS FOR HER SITE INFECTION. SHE ALSO STATED THAT HER DOCTOR ADVISED HER NOT TO USE THE ALCOHOL WIPES ANYMORE. ATTEMPTS WERE MADE TO REACH THE PATIENT TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT BUT THERE WAS NO ANSWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300986 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other