BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4161922 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36111
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    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
    VA
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 500 MG/DL. THE CUSTOMER REPORTED HAVING MULTIPLE ISSUES WITH THE SENSORS AND TRANSMITTER OF THE INSULIN PUMP. THE CUSTOMER REPORTED THAT THE SENSOR WAS NOT ADHERING TO THE SKIN. THE CUSTOMER ALSO REPORTED THAT THE SENSOR WOULD ONLY LAST A FEW DAYS BEFORE AN ALERT TO CHANGE IT IS RECEIVED BY THE CUSTOMER. THE CUSTOMER ALSO REPORTED THAT THE TRANSMITTER OF THE INSULIN PUMP WOULD NOT HOLD A CHARGE FOR LONG. THE CUSTOMER FURTHER REPORTED EXPERIENCING SKIN IRRITATION AT THE INFUSION AND SENSOR SITES FOR THE INSULIN PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644103 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR