BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3830396 · Received May 13, 2014

    Report

    Report Number
    3004464228-2014-00650
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE OF THE NEEDLE MECHANISM TO PROPERLY DEPLOY THE CANNULA OR TO DETERMINE ITS ROOT CAUSE. 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. THE PDM WILL AUTOMATICALLY REMIND YOU TO CHECK YOUR BLOOD GLUCOSE 1.5 HOURS AFTER EACH POD CHANGE. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT. VERIFY THERE IS NO WETNESS OR SCENT OF INSULIN, WHICH MAY INDICATE THE CANNULA HAS DISLODGED," 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 DO 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 SHE WAS NOT SURE IF THE CANNULA WAS INSERTED PROPERLY AT THE INFUSION SITE. HER BLOOD GLUCOSE WAS 416 MG/DL AT 8:45 AM AND ROSE TO 411MG/DL BY 8:57 AM. WHEN THE CUSTOMER REMOVED THE POD, SHE NOTICED THAT THE CANNULA WASN'T PROPERLY INSERTED AT THE INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285399 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 1400 L40495

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR