BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1060993 · Received June 12, 2008

    Report

    Report Number
    3004464228-2008-00105
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 12, 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 CALLED TO REPORT HIGH BLOOD SUGARS SINCE HE ACTIVATED THIS POD A LITTLE UNDER 24 HOURS AGO, AND DID NOT BELIEVE IT WAS DELIVERING THE BASAL OR BOLUSES HE'S ENTERED. HE STATED THE INSULIN MIGHT HAVE BEEN GOING SOMEWHERE, BUT HE WAS NOT RECEIVING IT. CUSTOMER CLAIMS THAT HE COULD SEE THROUGH THE WINDOW AND THE CANNULA WAS IN THE SUBCUTANEOUS AREA. HE OBSERVED THE POD AFTER HE REMOVED IT AND HE STATED THAT CANNULA WAS NOT BENT, AND NO BLOOD WAS AROUND THE SIGHT OR IN THE CANNULA. CUSTOMER STATED HE ACTIVATED POD AT 10:47 IN 2008. HIS BG LEVELS FLUCTUATED BETWEEN 200 AND 400 UNTIL 10:00 THE NEXT DAY WHEN HE REMOVED THE POD, BUT DID NOT DEACTIVATE IT BECAUSE HE WANT TO SEE IF POD WAS ACTUALLY DELIVERING INSULIN AFTER A BOLUS. THE CUSTOMER STATED THAT BEFORE DEACTIVATING THE POD, HE PROMPTED THE POD TO DELIVER 2U OF INSULIN AND DID NOT SEE ANY INSULIN COME OUT OF CANNULA. HE LATER DEACTIVATED THE POD AND ACTIVATED A NEW ONE. 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 L11700

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other