BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1913041 · Received November 19, 2010

    Report

    Report Number
    3004464228-2010-01380
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    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 DISCOLORATION AND RESIDUAL FLUID ON THE SURFACES OF INTERNAL ASSEMBLIES, WHICH IS INDICATIVE OF A FLUID LEAK. 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 POD 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 REPORTED THAT HE HAD EXPERIENCED CONTINUOUSLY HIGH BG LEVELS (250-312 MG/DL) OVER A 12 HOUR PERIOD WHILE WEARING THE POD; THE DEVICE THEN TERMINATED WITH A OCCLUSION ALARM. INSULET CUSTOMER SUPPORT REVIEWED THE CAUSES OF OCCLUSION ALARMS WITH THE CUSTOMER AND EXPLANTED THE IMPORTANCE OF SITE ROTATION IN ORDER TO AVOID THEIR RECURRENCE. 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 CORP 11200 L30381

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other