BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2933041 · Received January 18, 2013

    Report

    Report Number
    3004464228-2013-00055
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 23, 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 DISCARDED AND WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PT'S KETOACIDOSIS. NO MALFUNCTION WAS ALLEGED BY THE CALLER. NO QUALIFICATION RECORD REVIEW COULD BE CONDUCTED BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED. 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 "IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH." IT ADVISES "THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS," AND "ONCE YOU HAVE BEGUN TREATMENT FOR HIGH BLOOD GLUCOSE, CHECK FOR KETONES. CHECK FOR KETONES ANY TIME YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE. IF KETONES ARE PRESENT, AND YOU ARE FEELING NAUSEATED OR ILL, IMMEDIATELY CALL YOUR HEALTHCARE PROVIDER FOR GUIDANCE."

    Description of Event or Problem · 1

    THE PT REPORTED THAT ON (B)(6) 2012 AT 9:08 PM, HIS BLOOD GLUCOSE MEASURED 368 MG/DL AND HE CORRECTED WITH AN INSULIN BOLUS OF 29.95 UNITS. AT THIS TIME, PT FELT VERY SICK AND WAS VOMITING, SO HE HAD HIS DAUGHTER DRIVE HIM TO THE EMERGENCY ROOM. UPON ARRIVAL, HIS BREATH SMELLED FRUITY AND HE WAS ADMITTED FOR DIABETIC KETOACIDOSIS. THE POD WAS DISCARDED AT THE HOSPITAL. HE WAS GIVEN BLOOD TESTS AND TREATED WITH AN IV DRIP. HE WAS RELEASED THE AFTERNOON OF (B)(6). HE STATED THAT A SECONDARY ILLNESS CAUSED HIS BG TO BE HIGH, THAT "IT WAS NOT THE POD THAT CAUSED THIS," BUT DID NOT REPORT ANY ADD'L DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28651 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization