BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1060743 · Received June 11, 2008

    Report

    Report Number
    3004464228-2008-00102
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 10, 2008
    Report Date
    May 12, 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 WAS 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

    A CUSTOMER CALLED TO REPORT HAVING HIGH BG IN THE 400'S AFTER A FEW HOURS OF USE, EVEN AFTER INITIATING CORRECTION BOLUSES. HE HAD NOTICED SOME CLICKING NOISES DURING FILLING THE POD WITH INSULIN. THE CALLER DID NOT HAVE THE PDM TO GIVE EXACT BG VALUES AND STATED THAT NO BLOOD WAS NOTED IN THE CANNULA. STATED THAT THERE MAY HAVE BEEN A SMALL KINK ON CANNULA. NO FURTHER PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11663

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other