BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2221618 · Received August 19, 2011

    Report

    Report Number
    3004464228-2011-00450
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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 POD WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. THE POD'S ALL HISTORY WAS NOT PROVIDED. THERE IS NO INDICATION THAT BASAL RATES OR BOLUS ATTEMPTS WERE INEFFECTIVE AT LOWERING BG LEVELS IF AND WHEN THEY WERE ADMINISTERED. (THE ONLY BOLUSES NOTED IN THE REPORT WERE TWO MANUAL INSULIN INJECTIONS). NO SPECIFIC POD FAILURE MODE WAS CITED. BASED ON THE INFO PROVIDED IN THE REPORT AND IN THE ABSENCE OF A DEVICE EVAL, WE CANNOT CONFIRM THAT A POD MALFUNCTION MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BG LEVELS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED. THE LOT PASSED THE ACCEPTANCE CRITERIA. NOTE: EVAL METHOD CODES ARE SPECIFIC TO ACTIVITIES PERFORMED DURING LOT QUALIFICATION, AND NOT TO ACTIVITIES PERFORMED ON THE SUBJECT POD (AS IT WAS NOT RETURNED FOR EVAL).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT "THROUGHOUT THE NIGHT HER BG'S WERE ELEVATING." HER BG LEVEL WAS 420MG/DL WHEN SHE WOKE THE NEXT MORNING. SHE ADMINISTERED A MANUAL INSULIN INJECTION IN RESPONSE (THOUGH ITS AFFECT ON HER BG'S IS NOT KNOWN). TWO HOURS LATER SHE GAVE HERSELF A SECOND INSULIN INJECTION AND CALLED PARAMEDICS, WHO "STAYED WITH HER UNTIL SHE CHANGED THE POD." (IT IS UNK WHAT FORM OF THERAPY, IF ANY, WAS ADMINISTERED BY THE PARAMEDICS.) "SHORTLY AFTER" ACTIVATING THE NEW POD SHE "WAS FINE AND HER BG'S WERE COMING DOWN." NO SPECIFIC ISSUE WITH THE POD WAS REPORTED. THE SUSPECT DEVICE WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30552

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention