BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920043 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86523
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    THE CALLER REPORTED THAT THE PARAMEDICS HAD TO BE CALLED BECAUSE HIS SON HAD A LOW BLOOD GLUCOSE OF 48 MG/DL WHICH WAS TREATED WITH FOOD AND JUICE. THE BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 211 MG/DL. TROUBLESHOOTING WAS PERFORMED ON THE INSULIN PUMP AND ALL FUNCTIONAL TESTS PASSED. THE DRIVE SUPPORT CAP WAS RECESSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395704 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention