BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3923703 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-86587
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER CALLED MENTIONING THAT CUSTOMER HAD RECENTLY BEEN HOSPITALIZED. CUSTOMER, HIMSELF, WAS LATER CONTACTED ABOUT DETAILS OF THE HOSPITALIZATION. CUSTOMER STATED HE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. HE STATED HE CHANGED HIS SET AND HIS BLOOD GLUCOSE STARTED TO RISE. HE COULD NOT GET HIS BLOOD GLUCOSE TO LOWER, SO HE WENT TO THE HOSPITAL. HE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. HIS BLOOD GLUCOSE LEVEL WAS 500 MG/DL. HE WAS WEARING THE DEVICE AT THE TIME OF HOSPITALIZATION. CUSTOMER WAS TAKEN OFF THE DEVICE WHEN HE WAS ADMITTED AND PUT BACK ON WHEN HE WAS RELEASED A FEW DAYS LATER. CUSTOMER DECLINED TROUBLE SHOOTING FOR THE DEVICE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399632 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization