BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2072598 · Received April 25, 2011

    Report

    Report Number
    3004464228-2011-00177
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM A BROKEN CANNULA OR OTHER PRODUCT CONDITION THAT COULD HAVE CAUSED OR CONTRIBUTED TO INTERRUPTED OR RESTRICTED INSULIN FLOW, RESULTING IN INEFFECTIVE INSULIN BOLUS ATTEMPTS. NO CONCLUSION CAN BE DRAWN AS TO WHETHER DEVICE MALFUNCTION CONTRIBUTED TO THE CUSTOMER'S HIGH BLOOD GLUCOSE LEVELS. THE OMNIPOD USER GUIDE INSTRUCTS CUSTOMERS TO "REPLACE THE POD" AND "CONTACT YOUR HEALTHCARE PROVIDER FOR GUIDANCE" IF BLOOD GLUCOSE LEVELS REMAIN HIGH FOR A TOTAL OF FOUR HOURS AFTER A CORRECTION BOLUS WAS FIRST ADMINISTERED. QUALIFICATION RECORDS FOR LOT L30470 WERE REVIEWED AND THE LOT MET ALL QUALIFICATION SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER APPLIED THE DEVICE ON THE NIGHT OF (B)(6) 2011 AND NOTICED THE NEXT MORNING THAT HIS BLOOD GLUCOSE WAS IN THE UPPER 300 MG/DL RANGE. HE CHECKED BLOOD GLUCOSE SEVERAL TIMES (NO SPECIFIC TIMES OR READINGS REPORTED) WITH SEVERAL INSULIN BOLUSES ADMINISTERED (NO EXACT TIMES OR DOSAGES REPORTED) WITHOUT SUCCESSFULLY LOWERING THE BLOOD GLUCOSE. HE FINALLY REALIZED THE CANNULA WAS NOT INSERTED PROPERLY IN THE TISSUE SITE AND NOTICED WETNESS ON HIS TEE SHIRT. HE ALSO MENTIONED THAT WHEN HE VIEWED THE CANNULA, IT WAS BROKEN. CUSTOMER DEACTIVATED AND REPLACED THE DEVICE AND ADMINISTERED A BOLUS MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30470

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other