BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1931742 · Received December 8, 2010

    Report

    Report Number
    3004464228-2010-01424
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 13, 2010
    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 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 - A TEAR WAS FOUND 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 FATHER REPORTED THAT WITHIN TWO HOURS OF ACTIVATING A NEW POD, IT INITIATED A HAZARD ALARM INDICATING THAT A BOLUS HAD BEEN INTERRUPTED. HE IMMEDIATELY REMOVED AND REPLACED THE DEVICE. AFTER APPLYING THE NEW POD, HE AND HIS SON HAD GONE OUT TO PLAY BASKETBALL "WHICH USUALLY BRINGS HIS BG'S DOWN," BUT HIS LEVELS CONTINUED TO RISE (HIS SON'S BG'S ROSE FROM 254-323MG/DL). HE THEREFORE WONDERS WHETHER THE POD THAT ALARMED HAD ACTUALLY DELIVERED ANY OF THE PROGRAMMED MEAL BOLUS PRIOR TO ALARMING. THE POD WILL 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 L30380

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other