BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 950640 · Received November 16, 2007

    Report

    Report Number
    3004464228-2007-00148
    Event Type
    Other
    Date Received
    November 16, 2007
    Report Date
    November 16, 2007
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WAS EVALUATED FOR DAMAGE AND/OR DEFECTS RELATED TO MANUFACTURING. NONE WERE NOTED. THE DISTAL TIP OF THE CANNULA WAS VISUALLY FOUND TO BE FOLDED IN ON ITSELF WITH DEFORMATION WITH NO OPENING REMAINING. THE POD WAS TESTED FOR FLOW AND FLUID WAS OBSERVED EXITING THE DISTAL TIP OF THE CANNULA. THIS DEMONSTRATED THE POD WAS NOT OCCLUDED INTERNALLY. THE RUN DATA FROM THE DEVICE WAS NOT AVAILABLE FOR DOWNLOAD DUE TO BATTERY FAILURE. THE DATA WOULD INDICATE IF THE MOTOR WAS WORKING AGAINST A RESTRICTION, LIMITING IT'S ABILITY TO PUMP INSULIN. UNABLE TO CONCLUSIVELY DETERMINE IF THE CANNULA WAS OCCLUDED. AS NOTED INT EH USER GUIDE, PATIENTS ARE ADVISED TO SELECT A POD PLACEMENT SITE CONSISTING OF FATTY SUBCUTANEOUS TISSUE AND TO PINCH THE SKIN AROUND THE POD UNTIL THE CANNULA INSERTS. THE USER IS ALSO INSTRUCTED IN THE USER GUIDE TO PERIODICALLY CHECK THEIR INFUSION SITE AND 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. A REVIEW OF THE DHR FOR THIS LOT NUMBER DOES NOT SHOW ANY ABNORMAL EVENTS OR TRENDS FROM MANUFACTURING AND TESTING. THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT HIGH BLOOD SUGAR LEVELS AND DKA AND WAS HOSPITALIZED FOR 1 NIGHT. SHE SAID SHE IS PINCHING UP SOME FAT AROUND THE INFUSION SITE AND THERE IS NO PAIN. NO PROBLEMS WERE NOTED WITH THE DEVICE. NO FURTHER INFORMATION REPORTED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11146

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other