BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2244829 · Received September 6, 2011

    Report

    Report Number
    3004464228-2011-00517
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 5, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO PRODUCT WAS RETURNED FOR EVALUATION, WE ARE UNABLE TO DETERMINE ANY MALFUNCTION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S DKA AND HOSPITALIZATION. THE CUSTOMER'S HCP DOES NOT KNOW WHAT CAUSED THE DKA AND THE CMS STATED THAT THE CUSTOMER'S GASTROPARESIS MAY HAVE BEEN A CONTRIBUTING FACTOR. WE HAVE NO INFORMATION REGARDING THE CUSTOMER'S BLOOD GLUCOSE HISTORY PRIOR TO BEING HOSPITALIZED WHICH MAKES IT IMPOSSIBLE TO DETERMINE IF THE DEVICE WAS A CONTRIBUTING FACTOR. THE CUSTOMER WAS OFF THE OMNIPOD FOR AN UNKNOWN AMOUNT OF TIME. THERE IS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S DKA. NO LOT NUMBER WAS PROVIDED SO WE ARE UNABLE TO EVALUATE THE QUALIFICATION RECORDS.

    Description of Event or Problem · 1

    A CLINICAL SERVICES MANAGER (CSM) MET WITH A CUSTOMER TO DISCUSS A PAST DKA INCIDENT. ON (B)(6) 2011, THE CUSTOMER WAS HOSPITALIZED WITH DKA AT THE (B)(6). THE "HCP [IS] NOT SURE WHY [THE] CUSTOMER WENT INTO DKA." NO SPECIFIC BLOOD GLUCOSE HISTORY LEADING UP TO THE EVENT WAS PROVIDED. THE CSM STATED "SHE HAS MULTIPLE CO-MORBIDITIES AND IS NON COMPLIANT." THE CSM EXPLAINED THAT THE CUSTOMER ALSO HAD "GASTROPARESIS THAT COULD HAVE CONTRIBUTED TO HER DKA." ON (B)(6) 2011, THE CSM WAS CALLED TO ASSIST THE PT WITH RESTARTING HER PUMP. THE PDM SOUNDED VARIOUS ALARMS INCLUDING EXPIRATION TYPE ALARMS AND AN ERROR DURING PRIMING. THE CUSTOMER WILL BE DISCHARGED SOON AND HAS AN APPOINTMENT WITH HER ENDOCRINOLOGIST. THE PODS WERE DISCARDED AND THEREFORE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization