BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4223332 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46774
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    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 421 MG/DL. THE CUSTOMER TREATED WITH THE INSULIN PUMP. THE MOTHER OF THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED METER BG NOW. THE MOTHER OF THE CUSTOMER ALSO REPORTED THAT THE SENSOR STATUS SHOWED THAT THE SENSOR CALIBRATION WAS PAST DUE. THE MOTHER OF THE CUSTOMER COULD NOT CALIBRATE AS THE INSULIN PUMP WOULD NOT ACCEPT BLOOD GLUCOSE READING ABOVE 400 MG/DL. THE CUSTOMER WAS ADVISED TO WAIT UNTIL THE BLOOD GLUCOSE NORMALIZES BEFORE CALIBRATING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707759 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR