BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6012945 · Received October 8, 2016

    Report

    Report Number
    2032227-2016-28664
    Event Type
    Injury
    Date Received
    October 8, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 10, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF ISSUES WITH HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 447MG/DL. THE CUSTOMER'S MOST CURRENT LEVEL WAS 410MG/DL. THE CUSTOMER STATES THEY TREATED WITH PUMP. TROUBLESHOOT WAS CONDUCTED. THE CUSTOMER WAS ADVISED TO CONDUCT FULL SET, RESERVOIR AND INSULIN CHANGE. THE CUSTOMER WAS ADVISED TO MONITOR THE DEVICE AND CALL BACK IF ISSUES PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664299 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other