BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN POD

    MDR report key: 1092923 · Received August 1, 2008

    Report

    Report Number
    3004464228-2008-00157
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    June 29, 2008
    Report Date
    July 1, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE 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

    A CUSTOMERS MOM CALLS TO REPORT THAT THE CHILD HAS BEEN STAYING WITH GRANDMOTHER IN GA, AND WAS TAKEN TO THE ER BECAUSE HIS BG WAS OVER 300, AND HE WAS VOMITING. HE SPENT 8-10 HOURS IN THE ER AND WAS SENT HOME. THE DEVICE WAS NOT REPLACED AND AFTER SOME PERIOD HIS BG WENT UP ABOVE 300 AGAIN, AND THE CHILD WAS THEN ADMITTED INTO THE HOSPITAL WHERE RECEIVED IV INSULIN, UNTIL HIS BG WAS UNDER CONTROL. CALLER STATED THAT THE POD MADE A CRUNCHING NOISE WHILE FILLING THEM WITH INSULIN AND WAS HARD TO FILL WITH INSULIN. THE CUSTOMER WAS STILL IN THE HOSPITAL AT THE TIME OF THE CALL. NO FURTHER INFORMATION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization