BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3010881 · Received March 6, 2013

    Report

    Report Number
    3004464228-2013-00191
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    October 1, 2011
    Report Date
    February 4, 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 WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PT'S DIABETIC KETOACIDOSIS AND HOSPITALIZATION. THE OMNIPOD USER GUIDE WARNS " PLEASE READ ALL THE INSTRUCTIONS PROVIDED IN THIS USER GUIDE AND PRACTICE THE BLOOD GLUCOSE TESTING PROCEDURES BEFORE USING THE SYSTEM. MONITOR YOUR BLOOD GLUCOSE WITH THE GUIDANCE OF YOUR HEALTHCARE PROVIDER. UNDETECTED HYPERGLYCEMIA OR HYPOGLYCEMIA CAN RESULT WITHOUT PROPER MONITORING." AND 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'S MOTHER REPORTED THAT HER DAUGHTER'S DOCTOR TOOK HER OFF THE OMNIPOD AFTER SHE'D BEEN IN THE HOSP FOR DIABETIC KETOACIDOSIS. IN A F/U CALL WITH THE PT AND HER MOTHER, THE PT INDICATED THAT THE HOSPITALIZATION OCCURRED IN (B)(6) 2011. SHE CORROBORATED HER MOTHER'S STATEMENT THAT SHE HAD BEEN ESTIMATING HER BLOOD GLUCOSE AND MANUALLY ENTERING VALUES WITHOUT TESTING. THE MOTHER ALSO STATED THAT HER DAUGHTER IS A BRITTLE DIABETIC WHO GOES FROM LOW TO HIGH AND HIGH TO LOW BG VERY QUICKLY. THE DAUGHTER HAD BEEN BACK ON INJECTIONS UNTIL RECENTLY, BUT IS DOING MUCH BETTER, SEEING A NEW DOCTOR, AND USING THE OMNIPOD SYSTEM AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96644 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization