BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUP

    MDR report key: 2632406 · Received June 22, 2012

    Report

    Report Number
    3004464228-2012-00247
    Event Type
    Injury
    Date Received
    June 22, 2012
    Date of Event
    May 23, 2012
    Report Date
    May 25, 2012
    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 NOT RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PT'S HYPERGLYCEMIA. QUALIFICATION RECORDS FOR THE PRODUCT LOT WERE REVIEWED AND ALL ACCEPTANCE CRITERIA WERE MET. THE OMNIPOD USER'S 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 ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER," AND ADVISES "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 GAIN 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. IF BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HOURS (A TOTAL OF FOUR HOURS), REPLACE THE POD. USE A NEW VIAL OF INSULIN TO FILL THE NEW POD. THEN CONTACT YOUR HEALTHCARE PROVIDER FOR GUIDANCE."

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE DEVICE WAS ACTIVATED AT 8:35 AM ON (B)(6) 2012. SHE WAS USING HER CONTINUOUS GLUCOSE MONITOR AND DID NOT HAVE HER BLOOD GLUCOSE HISTORY LEADING UP TO THE EVENT RECORDED. ON (B)(6) 2012, SHE WENT TO THE HOSP AND WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH BG OF 575 MG/DL. SHE WAS TREATED WITH AN INSULIN DRIP. THE DEVICE WAS REMOVED AT THE HOSP AND DISCARDED. HER BG AT THE TIME OF HER CALL WAS IN THE 120 TO 130 MG/DL RANGE AND SHE WAS TO BE RELEASED AS SOON AS SHE ACTIVATED A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30817

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization