BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1051333 · Received May 23, 2008

    Report

    Report Number
    3004464228-2008-00074
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 23, 2008
    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 HAS NOT BEEN RETURNED, SO NO EVALUATION IS POSSIBLE. THE CUSTOMER FELT RESISTANCE DURING THE FILL PROCESS, WHICH INDICATES A PROBABLE PROBLEM WITH A RETAINER THAT ALLOWED A COMPONENT TO MOVE RESULTING IN DAMAGE WHICH PREVENTED THE PLUNGER FROM ADVANCING. THE USER WOULD HAVE BEEN AWARE OF A PROBLEM DURING THE FILL PROCESS. THERE IS RESISTANCE FELT IN FILLING THE POD WITH INSULIN AND A DISTINCT "CRACKLING" NOISE RESULTING FROM STRIPPING THE THREADS OF THE COMPONENT WHEN OVER-PRESSURISED. THE USER IS INSTRUCTED IN THE USER GUIDE TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THESE RECOMMENDATIONS, THE USER WOULD BECOME AWARE OF HIGH BG LEVELS AND COULD USE ANOTHER DEVICE OR BACKUP THERAPY IF REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A POD ALARMED AFTER MANIPULATING SYRINGE TO FILL IT WITH INSULIN. THE USER STATED IT WAS VERY DIFFICULT. HIS BG LEVELS WERE AT 400 WHEN HE REALIZED POD NOT DELIVERING INSULIN AFTER TWO HOURS HAD ELAPSED. THE PATIENT TRIED TO ACTIVATE NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11619

    Patients

    Seq Age Sex Outcome Treatment
    1 Other