BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1070440 · Received July 1, 2008

    Report

    Report Number
    3004464228-2008-00127
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    April 19, 2008
    Report Date
    June 1, 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 THIS RECOMMENDATION, 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 RETURNED THIS POD WITH THE PRODUCT FROM ANOTHER COMPLAINT. AN ENCLOSED NOTE DESCRIBING HER PROBLEM. THE POD WAS PUT IN USE IN 2008. IN THE NEXT DAY, HER BLOOD SUGAR WAS FINE IN THE MORNING, BUT BY 2PM OR SO WAS READING "HIGH", WITH APPARENT REASON. SHE INITIATED A BOLUS TO BRING HER BG DOWN BUT HOURS LATER WAS STILL READING HIGH. SHE REMOVED THE POD FROM HER ABDOMEN IN ORDER TO CHANGE TO A NEW POD AND NOTED THAT THE CANNULA HAD BLOOD IN IT. SHE THEN INITIATED ANOTHER BOLUS AND NO INSULIN WAS OBSERVED AT THE CANNULA. NO OCCLUSION ALARM OR OTHER ALARMS WERE REPORTED. NO FURTHER PROBLEMS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11561

    Patients

    Seq Age Sex Outcome Treatment
    1 Other