BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2903638 · Received January 3, 2013

    Report

    Report Number
    3004464228-2013-00005
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    August 1, 2012
    Report Date
    December 5, 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 PRODUCT DEFECT COULD HAVE CONTRIBUTED TO THE PT'S HYPERGLYCEMIA. AS NO PRODUCT LOT NUMBER WAS REPORTED, NO QUALIFICATION RECORD REVIEW COULD BE PERFORMED. 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 CAUTIONS "KEEP AN EMERGENCY KIT WITH YOU AT ALL TIMES TO QUICKLY RESPOND TO ANY DIABETES EMERGENCY. THE KIT SHOULD INCLUDE SEVERAL NEW, SEALED PODS; A VIAL OF RAPID-ACTING U-100 INSULIN; SYRINGES FOR INJECTING INSULIN' AND INSTRUCTIONS FROM YOUR HEALTHCARE PROVIDER ABOUT HOW MUCH INSULIN TO INJECT IF DELIVERY FROM THE POD IS INTERRUPTED". IT ADVISES "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE 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 YOU FEEL NAUSEATED AT ANY POINT, CHECK FOR KETONES AND CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY. 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 BACK IN (B)(6), HE WAS AT A TENNIS TOURNAMENT AND FELT ILL. HE TESTED HIS BLOOD GLUCOSE AND IT WAS HIGH. HE DRANK WATER CONTINUOUSLY AND CONTINUED TO TEST BG UNTIL HE DECIDED HE NEEDED TO GO HOME. HIS FATHER TOOK HIM TO THE MILITARY HOSPITAL IN (B)(6). UPON ARRIVAL, HIS BG MEASURED 560 MG/DL. HE WAS TREATED WITH AN IV AND REMAINED AT THE HOSPITAL FOR 7 TO 8 HOURS BEFORE BEING RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3535 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 1120

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization