BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3100035 · Received April 29, 2013

    Report

    Report Number
    3004464228-2013-00395
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    March 31, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. WE ARE ALSO UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED PAIN DURING ACTIVATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL CRITERIA. THE OMNIPOD USER GUIDE WARNS: "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 THE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." AND ADVISES "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL AND BEFORE GOING TO BED)."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS PAIN DURING ACTIVATION OF THE POD. ON (B)(6), THE SECOND DAY OF WEAR, HER BLOOD GLUCOSE MEASURED 187 MG/DL AT 6:58 AM AND SHE TOOK A 2.1 UNIT INSULIN BOLUS. AT 12:06 PM HER BG WAS 318 MG/DL WHICH SHE CORRECTED WITH A 5.3 UNIT BOLUS, BUT AT 1:01 MP HER BG WAS 323 MG/DL. SHE DEACTIVATED THE DEVICE AT 1:09 PM AND STATED THAT THE CANNULA WAS BENT "IN A COUPLE OF PLACES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184410 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31060

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR