BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1053466 · Received May 28, 2008

    Report

    Report Number
    3004464228-2008-00077
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 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 EVALUATION 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

    A CUSTOMER CALLED TO REPORT "HI" BLOOD GLUCOSE READING FOR LAST FEW HOURS DESPITE BOLUSES. SHE HAD BEEN WEARING THE POD APPROX 8 HOURS. SHE REPORTED THAT SHE HEARD A CLICKING NOISE WHEN FILLING WITH INSULIN. THE CUSTOMER WAS ADVISED NOT THE USE POD IF SHE HEARS CLICKING NOISES DURING FILL IN THE FUTURE. SHE DID NOT SEE BLOOD OR KINKS ON CANNULA WHEN SHE REMOVED THE POD, AND DID NOT NOTICE ANY WETNESS OR SMELL INSULIN. SHE THEN WAS ABLE TO ACTIVATE NEW POD AND GAVE SELF A CORRECTION BOLUS. THERE WERE 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 L11637

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other