BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2033080 · Received February 28, 2011

    Report

    Report Number
    3004464228-2011-00090
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    INSULET CORP
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED POD FOUND EVIDENCE OF AN INTERNAL FLUID LEAK - DISCOLORATION WAS SEEN INSIDE THE DEVICE. A LEAK TEST WAS PERFORMED, WHICH CONFIRMED THE PRESENCE OF A LEAK IN THE FLUID PATH CAUSED BY A TEAR IN THE CANNULA TUBING. THE LEAK WOULD HAVE RESULTED IN INSULIN COMING INTO CONTACT WITH INTERNAL COMPONENTS AND ASSEMBLIES, ULTIMATELY CAUSING THE DEVICE TO FAIL. A POD MALFUNCTION, THEREFORE, IS CONFIRMED TO HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BG LEVELS.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE REPORTED THAT HER HUSBAND ACTIVATED A NEW POD BEFORE GOING TO BED. THROUGHOUT THE NIGHT HIS BG LEVELS WERE BELOW 250MG/DL, BUT IN THE MORNING HIS LEVELS BEGAN TO RISE. IN RESPONSE TO AN ELEVATED BG OF 223MG/DL, A CORRECTION BOLUS WAS ADMINISTERED. AN HOUR LATER, HOWEVER, HIS BG LEVEL HAD RISEN TO 250MG/DL - ANOTHER CORRECTION BOLUS WAS ADMINISTERED. TWO HOURS LATER, HIS BG'S CONTINUED TO RISE - A HIGH READING OF 272MG/DL WAS EXPERIENCED. THE POD WAS REMOVED AND REPLACED, AND ANOTHER CORRECTION BOLUS WAS ADMINISTERED. THE POD 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 CORP 11200 L30448

    Patients

    Seq Age Sex Outcome Treatment
    1 Other