BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4100786 · Received September 16, 2014

    Report

    Report Number
    2032227-2014-23415
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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. THE 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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 489 MG/DL. THE CUSTOMER REPORTED TREATING WITH MANUAL INSULIN INJECTIONS. TROUBLESHOOTING WAS DONE. THE CUSTOMER STATES THE CANNULA WAS OCCLUDED. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET, RESERVOIR AND INSULIN OF THE INSULIN PUMP. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572059 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR