BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5092688 · Received September 21, 2015

    Report

    Report Number
    2032227-2015-47032
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    August 7, 2015
    Report Date
    September 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE BEEN HOSPITALIZED ON (B)(6) 2015 WITH BLOOD GLUCOSE OF 200 MG/DL. CUSTOMER HAD SYMPTOM OF BAD CRAMPING FROM TOES TO CHEST. CUSTOMER WAS HOSPITALIZED DUE TO DEHYDRATION. CUSTOMER WAS HOSPITALIZED FOR FOUR DAYS AND WAS TREATED WITH IV FLUIDS AND OTHER FLUIDS. CUSTOMER WAS WEARING INSULIN PUMP AT THE TIME OF HOSPITALIZATION. CUSTOMER REQUESTED AND RECEIVED EDUCATION ON CALIBRATING INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623876 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization