BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2170687 · Received July 12, 2011

    Report

    Report Number
    3004464228-2011-00338
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 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 EVALUATION. WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO HIGH OR LOW BG LEVELS. NO SPECIFIC FAILURE MODE WAS NOTED IN THE REPORT. BASED ON THE INFORMATION PROVIDED AND IN THE ABSENCE OF A DEVICE EVALUATION, WE CANNOT CONFIRM THAT A POD MALFUNCTION WAS A CONTRIBUTING FACTOR TO THE EVENT. NO CONCLUSION CAN BE DRAWN. THE PDM INVOLVED IN THE INCIDENT IS NOT BEING RETURNED FOR EVALUATION. WE ARE UNABLE TO EVALUATE THE DEVICE FOR ANY ISSUE THAT MAY HAVE RESULTED IN THE HIGH (318MG/DL) AND LOW (61 / 57MG/DL) BG READINGS WITHIN A 17 MINUTE PERIOD. IT IS UNKNOWN WHAT MAY HAVE CAUSED THIS DISCREPANCY IN BG READINGS. BUILT INTO THE POD'S DESIGN ARE ELECTRICAL, MECHANICAL AND SOFTWARE SAFETY FEATURES THAT PREVENT THE DEVICE FROM OVER-DELIVERING INSULIN (WHICH CAN RESULT IN HYPOGLYCEMIA). A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED AND NO FAILURES WERE FOUND - THE LOT PASSED THE ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED "EXTREME HIGH TO EXTREME LOW" BG LEVELS WITH THIS POD THAT RESULTED IN HER "FEELING REALLY BAD AT ONE POINT." HER LEVELS HAD ESCALATED TO A HIGH OF 318MG/DL WHILE DRIVING HOME FROM WORK; WHEN ARRIVING AT HOME, SHE "NEEDED ASSISTANCE IN GETTING OUT OF THE CAR." WHEN SHE TESTED HER BG'S OVER THE FOLLOWING 17 MINUTES, HOWEVER, SHE HAD LOW READINGS OF 61 AND 57MG/DL. "EMERGENCY RESPONSE" WAS CALLED AT THIS POINT; HER LOW BG LEVELS WERE "TREATED WITH APPLE JUICE." SHE CONTINUED TO WEAR THE POD FOR THE DURATION OF ITS INTENDED LIFE "SO SHE COULD STAY ON SCHEDULE." THE BG HISTORY PROVIDED IN THE REPORT INDICATES THAT HER LEVELS HAD NORMALIZED OVER THE REMAINDER OF POD WEAR; HER BG WAS 140MG/DL AT THE TIME IT WAS CHANGED THE FOLLOWING MORNING. NO SPECIFIC POD ISSUE WAS CITED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30506

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention