BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1030863 · Received April 7, 2008

    Report

    Report Number
    3004464228-2008-00020
    Event Type
    Malfunction
    Date Received
    April 7, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 8, 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 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 THAT SHE HAD VERY HIGH BG READINGS THIS MORNING. HER BG YESTERDAY WERE FINE. SHE DOES NOT THINK HER POD WAS DELIVERING INSULIN LAST NIGHT. CUSTOMER'S HISTORY IS AS FOLLOWS: 2008 9:00 PM - BG 229, CUSTOMER GAVE HERSELF A CORRECTION BOLUS OF 2.0 UNITS THROUGH HER PDM. AT 10:03 PM - DEACTIVATED 10:08 PM - BASAL .55 THE NEXT DAY. AT 12:00 AM - BASAL .55 2:00 AM - BASAL -65. 5:00 AM - BASAL .75 7:06 AM - BG 430, CUSTOMER GAVE HERSELF A 4.75 UNIT CORRECTION BOLUS THROUGH HER PDM. AT 7:55 AM - BG 400 - CUSTOMER DID NOT CORRECT THIS. CUSTOMER CALLED THE SUPPORT LINE AT THIS TIME. ADVISED THE CUSTOMER TO CHANGE THIS POD. CUSTOMER WILL CHANGE POD AND GIVE HERSELF AN APPROPRIATE CORRECTION BOLUS. 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 L11534

    Patients

    Seq Age Sex Outcome Treatment
    1 Other