BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4223316 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46749
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE PER VARIANCE 5.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER REPORTED HIS SON'S BLOOD GLUCOSE WAS FLUCTUATING FOR THE PAST WEEK. THE FATHER BELIEVED THERE WAS A PROBLEM WITH THE INSULIN PUMP AND SENSOR. THE CUSTOMER'S BLOOD GLUCOSE WAS 530 MG/DL. THE FATHER STATED HIS SENSOR GLUCOSE WAS SHOWING 76 MG/DL. THE FATHER ALSO REPORTED GIVING HIS SON A DUAL SQUARE WAVE BOLUS THAT WAS NOT RECORDED IN THE BOLUS WIZARD HISTORY. AT THE END OF THE CALL THE FATHER MENTIONED HE MAY HAVE NOT ADMINISTERED A DUAL SQUARE WAVE BOLUS, HENCE NOTHING WAS RECORDED. THE FATHER STATED HE WOULD CALL BACK TO TROUBLESHOOT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708325 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR