BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3060621 · Received March 26, 2013

    Report

    Report Number
    3004464228-2013-00261
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    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 RETURNED DEVICE WAS EVALUATED, AND THE REPORTED MALFUNCTION WAS CONFIRMED. ITS ROOT CAUSE WAS DETERMINED TO BE AN ASSEMBLY ERROR. THE RELEASE BAR WAS INSTALLED INCORRECTLY. AN INVESTIGATION INTO THIS ISSUE WAS CONDUCTED AND MFG WORK INSTRUCTIONS AND TRAINING PROCEDURES WERE UPDATED. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS, "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT" AND "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER WEARING THE POD FOR A COUPLE OF HOURS, HIS BLOOD GLUCOSE WAS 439 MG/DL. HE STATED THAT BEFORE HE CHANGED THE POD, IT WAS 277 MG/DL. WHEN HE REMOVED THE POD, HE NOTICED THAT THE CANNULA WAS NOT OUT AND HAD NOT DEPLOYED. HE SAID THAT THE "CLICKS DID NOT SOUND THE SAME," AND HE ALSO DID NOT FEEL THE CANNULA INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123155 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30974

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR