BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3885139 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-85948
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 DUE TO LOW BLOOD GLUCOSE. CUSTOMER STATED HE RECEIVED A LOST SENSOR SIGNAL. CUSTOMER DISCONTINUED THE SENSOR FOR A MONTH, WHICH CAUSED HIS BLOOD GLUCOSE LEVEL TO GO LOW. PARAMEDICS WERE CONTACTED, AT THE TIME OF HOSPITALIZATION THE CUSTOMER'S BLOOD GLUCOSE WAS 20MG/DL. CUSTOMER STATED THE CAUSED OF THIS EVENT WAS DUE TO TURNING OFF THE SENSOR, DUE TO THE LOST SENSOR ALARM AND PHYSICAL ACTIVITIES. THE BLOOD GLUCOSE READING WAS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361037 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization