BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4150002 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34797
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL NURSE THAT THE CUSTOMER HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS ON (B)(6) 2014. CUSTOMER WAS WEARING DEVICE AT TIME OF HOSPITALIZATION BUT WAS REMOVED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627540 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization