BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3170131 · Received June 6, 2013

    Report

    Report Number
    3004464228-2013-00576
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 11, 2013
    Manufacturer
    INSULET CORP
    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 EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PT'S DIABETIC KETOACIDOSIS AND COMA. NO PRODUCT LOT NUMBER WAS PROVIDED, SO NO QUALIFICATION RECORDS WERE REVIEWED. THE OMINPOD USER GUIDE WARNS "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS "HIGH CHECK FOR KETONES!" THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE), "HIGH" BLOOD GLUCOSE READINGS CAN INDICATE A POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH," AND "IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH" 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 HE WAS HOSPITALIZED FOR A FEW DAYS WITH DIABETIC KETOACIDOSIS AND IN A COMA. HIS BLOOD GLUCOSE WAS OVER 500 MG/DL. HE HAS ALSO EXPERIENCED BG AS LOW AS 22 MG/DL, BUT HAD NO EXACT TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252034 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization