BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3162095 · Received May 30, 2013

    Report

    Report Number
    3004464228-2013-00521
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 1, 2013
    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 EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR HYPERGLYCEMIA. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "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, BUT HAVE NO SYMPTOMS OF HIGH BLOOD GLUCOSE, THEN RETEST WITH A NEW TEST STRIP ON YOUR FINGERS. IF YOU STILL GET A 'HIGH CHECK FOR KETONES!' READING, PERFORM A CONTROL SOLUTION TEST TO ENSURE YOUR SYSTEM IS WORKING PROPERLY. IF THE SYSTEM IS WORKING PROPERLY, 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)."

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE WAS HOSPITALIZED FOR TWO DAYS IN FEBRUARY. HE DID NOT KNOW THE EXACT DATE OF THE HOSPITALIZATION. HE SAID THAT HIS BLOOD GLUCOSE RESULTS ON THE PDM WERE RUNNING "HIGH" (>500 MG/DL), AND WHEN HE WENT TO THE HOSPITAL, HIS RESULTS WERE "IN THE 800S". HE SAID HE WAS TREATED WITH INSULIN AND HIS BLOOD GLUCOSE RESULTS WERE CHECKED THROUGHOUT HIS STAY UNTIL THEY WERE BACK TO NORMAL. HE WAS RELEASED ON THE SECOND DAY. THE PATIENT WAS UNABLE TO FIND THE DATE WHEN THE EVENT OCCURRED AND COULD NOT PROVIDE BLOOD GLUCOSE RESULTS FROM THE PDM. HE NO LONGER HAD THE POD SO HE WAS UNABLE TO PROVIDE THE PRODUCT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238489 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization