BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1982172 · Received January 18, 2011

    Report

    Report Number
    3004464228-2011-00022
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 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 AND RESIDUAL FLUID AND CORROSION WAS FOUND ON THE SURFACES OF INTERNAL ASSEMBLIES. 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 REPORT INDICATED THAT THE CUSTOMER'S BG LEVELS WERE CONTINUOUSLY HIGH (258-396 MG/DL) OVER A 13 HOUR PERIOD AFTER APPLYING A NEW POD; MULTIPLE CORRECTION BOLUSES WERE ADMINISTERED DURING THIS TIME, BUT HER LEVELS WOULD NOT LOWER. SHE DEACTIVATED THE POD AND "MANUALLY CORRECTED"; SHE WILL CONTINUE TO MONITOR HER BG LEVELS AND ADMINISTER MANUAL INSULIN INJECTIONS UNTIL HER LEVELS ARE "BACK IN RANGE" - ONLY THEN WILL SHE APPLY A NEW POD. 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 L30385

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other