BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1112054 · Received August 5, 2008

    Report

    Report Number
    3004464228-2008-00167
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 12, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED SO NO EVALUATION IS POSSIBLE. THE CUSTOMER NOTICED A "CRACKLING" SOUND DURING THE FILL PROCESS WHICH INDICATES A PROBABLE PROBLEM WITH THE RETAINER THAT ALLOWED A COMPONENT TO MOVE RESULTING IN DAMAGE. THIS DAMAGE 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 OMNIPOD USER GUIDE STATES: "WARNING: NEVER USED 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 MONITOR BLOOD GLUCOSE LEVELS FREQUENTLY. BY FOLLOWING THESE RECOMMENDATIONS, THE USER BECAME AWARE OF THEIR HIGH BLOOD GLUCOSE AND STARTED A NEW POD OR BACKUP THERAPY IF NEEDED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT POD CRACKING SOUNDS AND RESISTANCE DURING FILL. CUSTOMER FORCED INSULIN INTO POD AND WAS ABLE TO ACTIVATE THE POD. CUSTOMER CALLED TO REPORT POD NOT DELIVERING INSULIN DUE TO RISING BLOOD GLUCOSE (BG) LEVELS. INFORMED CUSTOMER THAT FILLING A POD SHOULD BE A SMOOTH PROCESS AND NO RESISTANCE SHOULD OCCUR. ALSO INFORMED HIM THAT CRACKING SOUNDS SHOULD NOT BE HEARD DURING FILL. CUSTOMER INSTRUCTED TO REPORT FUTURE PODS THAT GIVE CRACKLING AND RESISTANCE DURING FILL AND NOT ACTIVATE THOSE. CUSTOMER VERBALIZED UNDERSTANDING AND WILL ACTIVATE A NEW POD TO TREAT ELEVATED BG'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11714

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR