BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3122490 · Received May 14, 2013

    Report

    Report Number
    3004464228-2013-00437
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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 NOT RETURNED FOR EVAL. 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 AND FEEL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA. 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, PERFORMED A CONTROL SOLUTION TEST TO ENSURE YOUR SYSTEM IS WORKING PROPERLY. IF THE 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 PT'S FATHER REPORTED THAT HIS SON WAS HOSPITALIZED WITH HYPERGLYCEMIA. HE STATED THAT HE HAD KETONES AND HIS BLOOD GLUCOSE RESULT WENT UP TO 648 MG/DL. THE FATHER SAID THAT HIS SON'S CONDITION WAS STABILIZED. BECAUSE HE WAS FAR FROM HOME, HE WANTED TO KNOW IF A CLINICAL SERVICES MANAGER COULD TAKE HIM A POD, AS THE HOSPITAL WANTED TO SEE HOW HE DID ON THE PRODUCT BEFORE RELEASING HIM FROM THE HOSPITAL. THE CLINICAL SERVICES MANAGER WAS ABLE TO GET PODS TO THE PT'S FATHER. THREE ATTEMPTS WERE MADE TO REACH OUT TO THE PT FOR MORE INFO AND THE MESSAGES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212183 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization