BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1082079 · Received July 25, 2008

    Report

    Report Number
    3004464228-2008-00142
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 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 FOR 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 SHIPPING THE THREADS OF THE COMPONENT WHEN OVER-PRESSURISED. THE OMNIPOD USER GUIDE STATES: "WARNING: NEVER USE A POD IF, DURING FILL, YOU DETECT ANY CRACKLING NOISE OR RESISTANCE WHILE DEPRESSING THE PLUNGER OF THE FILL SYRINGE. USING A POD WITH THESE CONDITIONS COULD RESULT IN UNDER-DELIVERY OF INSULIN." THE USER IS ALSO INSTRUCTED IN THE USER GUIDE TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THESE RECOMMENDATION, 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'S WIFE CALLED TO REPORT THAT HER HUSBAND WOKE UP TO A HIGH BG LEVEL. THE POD WAS PLACED AT 8PM, AND DEACTIVATED AT 9:30 AM. HE GAVE HIMSELF A MANUAL BOLUS OF 6U WHILE ON THE PHONE. SHE STATED THAT HE DID EXPERIENCE AN AUDIBLE CRACKLING WHILE FILLING THE POD, YET PLACED IT IN USE ANYWAY. THE CUSTOMER THEN ACTIVATED AND PLACED NEW POD, AND HIS BG WENT BACK DOWN TO 132. 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 L11744

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other