BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INCULIN PUMP

    MDR report key: 1030866 · Received April 8, 2008

    Report

    Report Number
    3004464228-2008-00023
    Event Type
    Malfunction
    Date Received
    April 8, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 5, 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

    RECEIVED A REPORT THAT CUSTOMER HAD REMOVED A POD AFTER ABOUT 12 HOURS WEAR. HIS BG AND BOLUS HISTORY AFTER ACTIVATING THE POD WERE AS FOLLOWS: 9:44P - ACTIVATED POD, BASAL 1.05U/HR. 9:50P - BG 283, 1.0U BOLUS. 12A - BASAL 1.05U/HR. 6:22A - BG 328, 3.6U BOLUS. 6:54A - 4.0U BOLUS. 7A - BASAL 0.90 U/HR. 7:30A - BASAL 1.05U/HR. 9:36A - BG HIGH, 9.0U BOLUS. 10:04A - BG HIGH, REMOVED POD. CALLER SAID HE DID NOT KNOW WHAT THE SITE LOOKED LIKE WHEN THE POD WAS REMOVED, BUT THE CANNULA DID NOT APPEAR BENT OR KINKED. THE CUSTOMER WAS ABLE TO ACTIVATE A NEW POD SUCCESSFULLY. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INCULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11519

    Patients

    Seq Age Sex Outcome Treatment
    1 Other