BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1060994 · Received June 12, 2008

    Report

    Report Number
    3004464228-2008-00104
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL INDICATES THAT A RETAINER 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 SAID HE REMOVED A POD AFTER 2.5 DAYS BECAUSE HIS BGS "WERE RUNNING BETWEEN 240 AND 340" FOR TWO DAYS, AND HE COULD NOT GET THEM TO COME DOWN, DESPITE REPEATED BOLUSES. HE SAID THAT WHEN HE FILLED THE POD, HE FELT "A LOT OF RESISTANCE." HE MENTIONED THAT HE WAS ABLE TO ACTIVATE A NEW POD SUCCESSFULLY AND HIS BG CAME DOWN. NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11657

    Patients

    Seq Age Sex Outcome Treatment
    1 Other