BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4133774 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-32015
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT FOR DIABETIC KETOACIDOSIS FROM (B)(6) 2014 - (B)(6) 2014. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF HOSPITALIZATION 605MG/DL. CUSTOMER ALSO REPORTED HAVING PREVIOUS HIGH BLOOD GLUCOSE LEVELS RANGING FROM 400MG/DL TO 500MG/DL. CUSTOMER ADVISED THAT THEY HAVE BEEN USING MANUAL INJECTIONS SINCE LEAVING THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611749 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization