BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1062809 · Received June 18, 2008

    Report

    Report Number
    3004464228-2008-00111
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 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 PRODUCT HAS NOT BEEN RETURNED SO NO EVALUATION WAS POSSIBLE. THE CUSTOMER FELT RESISTANCE DURING THE FILL PROCESS, WHICH INDICATES A PROBABLE PROBLEM WITH A RETAINER THAT ALLOWED A COMPONENT TO MOVE RESULTING IN DAMAGE WHICH 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-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 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 A POD WITH A CRACKLING SOUND DURING THE FILL PROCESS. SHE STATES THAT SHE WAS AWARE OF THE INSTRUCTIONS NOT TO WEAR A POD WHEN THIS CONDITION WAS NOTED, BUT DECIDED SHE WOULD GO AHEAD AND USE THE POD. AFTER FOUR HOURS HER BG WENT INTO THE 400'S. 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 L11663

    Patients

    Seq Age Sex Outcome Treatment
    1 Other