BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2944219 · Received January 9, 2013

    Report

    Report Number
    3004464228-2013-00017
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 10, 2012
    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 DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR DEFECT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT THE CANNULA HAD NOT INSERTED PROPERLY. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HIGH BLOOD GLUCOSE. THE OMNIPOD USER GUIDE WARNS "CHECK THE INFUSION SITE AFTER INSERTION TO ENURE 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." QUALIFICATIONS RECORDS ARE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE WAS IN THE RANGE OF 300 TO 400 MG/DL USING A CONTINUOUS GLUCOSE MONITOR. HE HAD TAKEN A STEROID INJECTION WHICH MAY HAVE ELEVATED HIS BLOOD GLUCOSE, BUT HE ALSO STATED THAT THE CANNULA WAS NOT INSERTED PROPERLY. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13128 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30938

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR