BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2195663 · Received July 27, 2011

    Report

    Report Number
    3004464228-2011-00381
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE DEVICE WAS TESTED IN THE LAB AND PERFORMED ACCORDING TO SPECIFICATIONS. UNABLE TO DETERMINE A MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE PATIENT'S DKA. THE USER GUIDE EMPHASIZES, "THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS." THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE QUALIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED WITH DKA. HER BLOOD GLUCOSE LEVEL WAS 440MG/DL AT TIME OF ADMISSION; NO PREVIOUS VALUES WERE REPORTED. PATIENT WAS PLACED ON AN INSULIN DRIP AND BG LEVELS DROPPED TO 200MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30480

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization