BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3012649 · Received February 21, 2013

    Report

    Report Number
    3004464228-2013-00144
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE BENT CONDITION OF THE CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS TO "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES!' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). IF YOU GET A 'HIGH CHECK FOR KETONES!' READING AND FEEL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA". IT 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)," AND "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER. CHECK BLOOD GLUCOSE AGAIN AFTER TWO HOURS. IF BLOOD GLUCOSE LEVELS HAVE NOT DECREASED, TAKE A SECOND BOLUS BY INJECTION, USING A STERILE SYRINGE. IF BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER TWO HOURS (A TOTAL OF FOUR HOURS), REPLACE THE POD."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE MEASURED 229 MG/DL AT 7:39 PM AND 218 MG/DL AT 5:51 PM. AT 11:04 PM HER BG READ "HIGH" (>500 MG/DL). NO TREATMENT WAS SPECIFIED AT THAT EXACT TIME, ALTHOUGH SHE DID REPORT THAT SHE WAS GIVING HERSELF MANUAL INJECTIONS, BUT DIDN'T KEEP NOTES. THE NEXT DAY AT 12:54 PM, SHE HAD A SNACK CONTAINING ABOUT 15 GRAMS OF CARBOHYDRATE AND HER BG WAS 367 MG/DL. SHE TOOK A BOLUS BY MANUAL INJECTION BUT DID NOT RECORD THE DOSAGE. WHEN SHE REMOVED THE POD AT 1:00 PM, THE CANNULA WAS BENT. SHE WAS TIRED, FRUSTRATED, EMOTIONAL, NAUSEATED, AND NOT FEELING WELL DURING THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77392 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31022

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR