BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1030862 · Received April 3, 2008

    Report

    Report Number
    3004464228-2008-00018
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 2, 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 THE THREADS OF A COMPONENT HAD ROUNDED OVER WHICH PREVENTED THE PLUNGER FROM ADVANCING. 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 COU LD USE ANOTHER DEVICE OR BACKUP THERAPY IF REQUIRED.

    Description of Event or Problem · 1

    MOTHER CALLED ON BEHALF OF HER DAUGHTER WHO IS A CUSTOMER. SHE SAID THAT THE POD HAD MADE NOISE WHEN THE POD WAS FILLED WITH INSULIN. THEY CHECKED HER BG 2 HOURS LATER AT 12AM AND HER BG WAS IN THE HIGH 400'S. THE MOTHER CALLED THE DOCTOR WHO INSTRUCTED HER TO SWITCH TO INJECTIONS. THEY REMOVED THE POD AND SUCCESSFULLY ACTIVATED A NEW POD. NO FURTHER INFORMATION 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 Other