BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3951357 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88067
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED. INITIALLY, THEY WENT TO THE HOSPITAL FOR URINARY TRACT INFECTION. THEN, THE NEXT DAY THEY WENT BACK TO THE HOSPITAL FOR HIGH BLOOD GLUCOSE AND WERE HOSPITALIZED. THE CUSTOMER DID NOT REMEMBER THEIR EXACT BLOOD GLUCOSE AT THE TIME OF THE HOSPITALIZATION BUT STATED THAT IT WAS BETWEEN 500 MG/DL AND 600 MG/DL. AT THE HOSPITAL THE CUSTOMER WAS TREATED WITH MANUAL INJECTION AND IV. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428445 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization