BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2081382 · Received April 29, 2011

    Report

    Report Number
    3004464228-2011-00186
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IS NOT EXPECTED TO RETURN TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY POTENTIAL MALFUNCTION OR PRODUCT CONDITION THAT COULD HAVE CONTRIBUTED TO THE PT'S HOSPITALIZATION. THE PT REPORTED THAT THE CANNULA APPEARED TO HAVE PULLED OUT OF THE INSERTION SITE, INTERRUPTING INSULIN DELIVERY, BUT NO BLOOD GLUCOSE HISTORY WAS REPORTED. NO CONCLUSION CAN BE DRAWN. THE OMNIPOD USER GUIDE INSTRUCTS THE PT TO "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." PT STATED SHE NEVER CHECKS THE CANNULA TO ENSURE IT IS PROPERLY INSERTED. IF FOLLOWING THE USER GUIDE INSTRUCTIONS, THE CUSTOMER WOULD HAVE IMMEDIATELY REMOVED AND REPLACED THE DEVICE UPON NOTICING THAT THE CANNULA ISSUE. REVIEW OF LOT QUALIFICATION RECORDS WAS NOT POSSIBLE BECAUSE NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PT STATED SHE HAD BEEN HOSPITALIZED BECAUSE THE DEVICE WAS NOT WORKING AND RESULTED IN HIGH BLOOD GLUCOSE, HOWEVER, NO SPECIFIC BLOOD GLUCOSE READINGS OR ATTEMPTED CORRECTIVE INSULIN BOLUSES WERE REPORTED. SHE ALSO MENTIONED THAT WHEN SHE REMOVED THE DEVICE SHE NOTICED THE CANNULA WAS NOT INSERTED IN THE SKIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization