BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3172783 · Received May 31, 2013

    Report

    Report Number
    3004464228-2013-00537
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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 CAUSED BY 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 SHE ACTIVATED A POD AT 4:45 AM. AT 5:59 AM, HER BLOOD GLUCOSE RESULT WAS 259 MG/DL, AND SHE GAVE HERSELF A 3/85U BOLUS. AT 8:27 AM, SHE CONSUMED 33 GRAMS OF CARBOHYDRATE AND GAVE HERSELF A 2.05U BOLUS. AT 11:54 AM, HER RESULT WAS 451 MG/DL. SHE GAVE HERSELF AN 8U BOLUS. SHE DEACTIVATED THE POD AT 2:32 PM. SHE STATED THAT THE NEEDLE NEVER CAME OUT ALL THE WAY, AND THE CANNULA NEVER CAME OUT. SHE DID NOT HEAR THE CLICK WHEN SHE ACTIVATED THE POD AND PRESSED START. SHE SAID THAT SHE GAVE HERSELF 10-15U FOUR TIMES AFTER SHE DEACTIVATED THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242416 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31096

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR