BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3001715 · Received March 7, 2013

    Report

    Report Number
    3004464228-2013-00200
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 4, 2013
    Report Date
    February 6, 2013
    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

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED HAZARD ALARM. HAZARD ALARMS ARE SAFETY FEATURES NOT CONSIDERED MALFUNCTION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT DEFECT OR DEFICIENCY CONTRIBUTED TO THE PT'S DIABETIC KETOACIDOSIS AND HOSPITALIZATION. NO QUALIFICATION RECORD REVIEW COULD BE CONDUCTED AS NO PRODUCT LOT NUMBER WAS REPORTED. THE OMNIPOD USER GUIDE WARNS "WHEN A HAZARD ALARM OCCURS IN THE POD, ALL INSULIN DELIVERY STOPS. FAILING TO ADDRESS THE SITUATION COULD RESULT IN HYPERGLYCEMIA. IF YOU HAD A TEMP BASAL OR EXTENDED BOLUS RUNNING WHEN THE HAZARD OCCURRED, THE PDM WILL REMIND YOU OF THIS," AND CAUTIONS "DUE TO THE SERIOUS NATURE OF HAZARD ALARMS, YOU MUST ACT PROMPTLY TO RESOLVE THEM. ACKNOWLEDGE THE ALARM CONDITION BY PRESSING OK, WHICH SILENCES THE ALARM. DEACTIVATE AND REMOVE THE ACTIVE POD. ACTIVATE AND APPLY A NEW POD." IT ADVISES "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."

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH BLOOD GLUCOSE MEASURING 773 MG/DL AT ADMISSION. SHE WAS TREATED WITH INSULIN AND SALINE DRIP. SHE HAD LAB WORK EVERY TWO HOURS AND BG TESTS EVERY HOUR. HER BG WHEN RELEASED WAS 200 MG/DL. THE POD, WHICH SHE REPORTED TERMINATED WITH A HAZARD ALARM (NO INFO WAS GIVEN ON THE TIMING OF THIS ALARM IN RELATION TO HER ADMISSION), WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96741 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization