BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3231967 · Received July 11, 2013

    Report

    Report Number
    3004464228-2013-00741
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 16, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS BELOW 70MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). TEST RESULTS GREATER THAN 250MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS BELOW 70MG/DL OR ABOVE 250MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70MG/DL OR ABOVE 250MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." IT ADVISED, "ALWAYS CHECK YOUR BLOOD GLUCOSE LEVELS FREQUENTLY WHILE TREATING HYPERGLYCEMIA. YOU DON'T WANT TO OVER-TREAT THE CONDITION AND CAUSE YOUR BG LEVEL TO DROP TOO FAR. CHECK YOU BLOOD GLUCOSE LEVEL. THE RESULT WILL HELP YOU TO FIND OUT HOW MUCH INSULIN IS NEEDED TO RETURN YOUR BLOOD GLUCOSE TO THE BG GOAL. IF YOUR BLOOD GLUCOSE IS 250MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE PRESENT, FOLLOW YOUR HEALTHCARE PROVIDER'S GUIDELINES. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER. CHECK BLOOD GLUCOSE AGAIN AFTER 2 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 2 HOURS (A TOTAL OF 4 HOURS), REPLACE THE POD."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(4), HIS BLOOD GLUCOSE RESULT WAS 16MMOL/L (288MG/DL) AND HE GAVE HIMSELF A MANUAL INJECTION. HE DID NOT REPORT THE TIME OF THE READING OR THE NUMBER OF UNITS. AT 9:30PM, HIS RESULT WAS 17.4MMOL/L (313MG/DL). HE DEACTIVATED THE POD AND GAVE HIMSELF AN INJECTION (UNITS NOT PROVIDED). AT 11:00PM, HIS RESULT WAS 19.1MMOL/L (344MG/DL). HE THEN WENT TO BED, AT MIDNIGHT HE TESTED HIS BLOOD GLUCOSE AND THE RESULT WAS 6.9MMOL/L (25MG/DL). HE STATED THAT THE MEDICS GAVE HIM AN INJECTION OF "SUGAR SOLUTION." HIS BLOOD GLUCOSE READINGS DURING THAT TIME WERE UNAVAILABLE, AS THE READING WERE TAKEN BY THE MEDICS. HE STATED THAT HE WOKE UP IN THE MORNING WITH A RESULT OF 11.0MMOL/L (198MG/DL). AT 9:00AM, HIS RESULT WAS 16.2MMOL/L (292MG/DL), WHICH HE STATED WAS HIGH BECAUSE OF THE INJECTION HE RECEIVED FROM THE MEDICS. HE GAVE HIMSELF A 9.0U BOLUS AND CONSUMED 71 GRAMS OF CARBOHYDRATE. AT 12:00PM, HE HAD A NEW POD ON AND HIS BLOOD GLUCOSE RESULT WAS 19.4MMOL/L (349MG/DL). AT THE TIME OF THE CALL, HE WAS STILL WEARING THE NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321099 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14820 L31059

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR