BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3010991 · Received March 15, 2013

    Report

    Report Number
    3004464228-2013-00222
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 13, 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 PRODUCT WAS RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION COULD HAVE CONTRIBUTED TO THE REPORTED DIABETIC KETOACIDOSIS, HEART ATTACK, AND HOSPITALIZATION. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS NO PRODUCT LOT NUMBER WAS PROVIDED. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER" 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" AND "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE PRESENT, FOLLOW YOUR HEALTHCARE PROVIDER'S GUIDELINES. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVELS HAVE NOT DECREASED, TAKE A SECOND BOLUS BY INJECTION, USING A STERILE SYRINGE. IF YOU FEEL NAUSEATED AT ANY POINT, CHECK FOR KETONES AND CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR 4 DAYS WITH DIABETIC KETOACIDOSIS. HER BLOOD GLUCOSE WAS 399 MG/DL, AND SHE SAID THAT SHE WAS VOMITING AND TAKEN TO THE HOSPITAL BY AMBULANCE. SHE SAID THAT HER PHYSICIAN TOLD HER SHE MAY HAVE HAD A MILD HEART ATTACK, BUT IT IS NOT CLEAR WHEN THE HEART ATTACK OCCURRED. THE CUSTOMER BELIEVES THAT THE POD WAS INVOLVED. SHE REPORTED THAT SHE COULD NOT GET HER BLOOD GLUCOSE TO DECREASE WITH THE POD SHE WAS WEARING, AND THAT IT WAS ON HER BACK, POSSIBLY TOO CLOSE TO HER SPINE. WHEN SHE CHANGED THE POD, SHE SAID THAT HER BLOOD GLUCOSE LEVEL STARTED TO DECREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110703 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization