BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2915555 · Received January 10, 2013

    Report

    Report Number
    3004464228-2013-00018
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE 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 SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER," AND ADVISES "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 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. USE A NEW VIAL OF INSULIN TO FILL THE NEW POD."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POD WAS ACTIVATED ON (B)(6) 2012 AT 6:24 PM AND HER BLOOD GLUCOSE MEASURED 83 MG/DL AT 10:24 PM. ON (B)(6) 2012 AT 8:34 AM HER BG WAS 224 MG/DL AND HER BREAKFAST CONTAINED ABOUT 40 GRAMS OF CARBOHYDRATE, SO SHE TOOK A 5.05 UNIT INSULIN BOLUS. BY 11:17 AM HER BG HAD REACHED 280 MG/DL; SHE CORRECTED WITH A 2 UNIT BOLUS. HER BG REMAINED ABOVE 250 MG/DL FOT THE NEXT 7 HOURS. A 5.3 UNIT BOLUS WAS DELIVERED AT 3:11 PM FOR CORRECTION AND FOR 40 GRAMS OF CARBOHYDRATE. AT 6:24 PM HER BG WAS 309 MG/DL AND SHE HAD MEDIUM KETONES, SO SHE WENT TO EMERGENCY ROOM. SHE WAS GIVEN 2 BAGS OF SALINE SOLUTION AND 6 UNITS OF HUMALIN, WHICH BROUGHT HER BG DOWN TO 185 MG/DL. THE PATIENT WAS RELEASED AFTER THAT AND DEACTIVATED THE POD AT 11:30 PM. THE PATIENT STATED THAT THERE WAS A RED SPOT ON SKIN WHERE CANNULA WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13543 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30932

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other