BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2860241 · Received November 2, 2012

    Report

    Report Number
    3004464228-2012-00558
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 6, 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

    RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. NO DEFECT OR DEFICIENCY THAT WOULD RESULT IN THE CANNULA FAILING TO INSERT CORRECTLY OR THE PUMP FAILING TO DELIVER WAS FOUND. THE CALLER REPORTED THAT SHE WAS NOT SURE THE CANNULA HAD INSERTED PROPERLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. IT CANNOT BE CONFIRMED OR EXCLUDED THROUGH LABORATORY TESTING. QUALIFICATION RECORDS FOR THE PRODUCT LOT WERE REVIEWED AND ALL ACCEPTANCE CRITERIA WERE MET. THE OMNIPOD'S USER GUIDE WARNS TO "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 ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE'S BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AND WASN'T SURE IF THE CANNULA WAS INSERTED IN THE INFUSION. THE CUSTOMER REPORTED THAT SHE ACTIVATED THE DEVICE ON (B)(6) 2012. AT 4:30 PM, BG: 274 A 2 UNIT BOLUS WAS ADMINISTERED. AT 5:01 PM, BG: 291 MG/DL A 1.6 UNIT BOLUS WAS ADMINISTERED. AT 5:17 PM, BG: 289 MG/DL A 0.5 UNIT BOLUS WAS ADMINISTERED. AT 5:51 PM, BG: 299 MG/DL ANOTHER 0.85 UNIT BOLUS WAS ADMINISTERED. AT 6:14 PM, BG: 315MG/DL BY 6:39 PM, BG: 320 MG/DL (NO INSULIN BOLUSES REPORTED AT THESE TIMES) SHE ALSO NOTICE BLOOD IN THE CANNULA WHEN DEACTIVATING THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30894

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR