BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3791233 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84348
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    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 EXPERIENCING HIGH BLOOD GLUCOSE. THE CURRENT BLOOD GLUCOSE READING IS 128 MG/DL. CUSTOMER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 548 MG/DL. CUSTOMER STATED THAT THE BLOOD GLUCOSE LEVELS WOULD NOT GO DOWN. CUSTOMER WAS NAUSEATED, IRRITABLE, THIRSTY AND FREQUENT URINATION. HOSPITAL TREATED WITH FIVE UNITS OF INSULIN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269401 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization