BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4123079 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29451
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 IS REPORTED THAT THE PATIENT EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL. LEVEL IS IN THE 400+ MG/DL. TROUBLE SHOOTING WAS CONDUCTED AND WE EXPLAINED THE POSSIBLE REASONS FOR A HIGH BLOOD GLUCOSE LEVEL TO THE PATIENT. THE DEVICE IS NOT BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600484 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR