BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2885130 · Received December 14, 2012

    Report

    Report Number
    3004464228-2012-00649
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND FOUND TO HAVE TERMINATED WITH AN OCCLUSION ALARM, THE ROOT CAUSE OF WHICH WAS DETERMINED TO BE A PHYSIOLOGICAL OCCLUSION. OCCLUSION ALARM IS A SAFETY FEATURE AND NOT A MALFUNCTION. THE AUDIBLE ALARM WAS ALSO TESTED AND PERFORMED AS INTENDED. NO OTHER DEFECT OR MALFUNCTION WAS FOUND TO HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND EMERGENCY VISIT. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER'S GUIDE WARNS "TEST RESULTS GRATER 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," 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 PATIENT CALLED TO REPORT LAST WEEK SHE WAS EXPERIENCING HYPERGLYCEMIA WITH BLOOD GLUCOSE GREATER THAN 500 MG/DL; POD WAS THEN DEACTIVATED AND SHE HAD TO GO TO THE EMERGENCY ROOM. AT THE EMERGENCY ROOM PATIENT WAS GIVEN INTRAVENOUS THERAPY TO TREAT HER BG OF 500 MG/DL. PATIENT ALSO GIVEN HERSELF A MANUAL INJECTION AND HER BG BEGAN TO COME DOWN (AMOUNT AND BG LEVEL NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30967

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other