BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2926205 · Received January 15, 2013

    Report

    Report Number
    3004464228-2013-00036
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 17, 2012
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    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 PATIENT¿S HYPERGLYCEMIA AND ER VISIT. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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 ABOUT 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER,¿ AND ADVISES TO ¿INVESTIGATE POSSIBLE CAUSE FOR HYPERGLYCEMIA TO AVOID SIMILAR PROBLEMS IN THE FUTURE,¿ AFTER TREATING HIGH BLOOD GLUCOSE.

    Description of Event or Problem · 1

    THE PATIENT¿S MOTHER REPORTED THAT HER SON HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE ¿ALL OVER.¿ HE DOESN¿T FEEL WELL, HIS VISION IS AFFECTED, HIS BELLY HURTS, AND HE FEELS BAD ALL OVER. SHE STATED THAT ABOUT TWO WEEKS PRIOR TO HER CALL HE WAS IN THE EMERGENCY ROOM WITH BG OF 657 MG/DL. HE WAS GIVEN FLUIDS AND RELEASED WITH BG OF 200 MG/DL. SHE THINKS SOMETHING IS WRONG WITH THE PDM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22934 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B L50026

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other