BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1061087 · Received June 13, 2008

    Report

    Report Number
    3004464228-2008-00107
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 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 EVAL 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-PRESSURIZED. 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 HIGH BG ALL DAY SINCE ACTIVATION OF A POD. LEVELS WERE UNCONTROLLED BY BOLUSES AND HE HAD SEVERE HYPERGLYCEMIC SYMPTOMS. CUSTOMER REMOVED POD WITHOUT DEACTIVATION AND PROMPTED POD TO BOLUS INSULIN. NO INSULIN WAS OBSERVED TO COME OUT OF CANNULA. HE STATED THAT HE HAD HEARD SOME CRUNCHING SOUNDS DURING FILLING. HIS BG REACHED 482, SO HE REMOVED THE POD AND CORRECTED WITH A MANUAL INJECTION OF INSULIN. HE LATER STATED THAT HIS BG HAD GONE DOWN TO 145 AFTER MANUAL INJECTION AND SMALL BOLUS WITH NEW POD AND HE NO LONGER HAD SYMPTOMS. 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 L11631

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other