BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5962224 · Received September 20, 2016

    Report

    Report Number
    3004209178-2016-77903
    Event Type
    Injury
    Date Received
    September 20, 2016
    Date of Event
    August 28, 2016
    Report Date
    August 28, 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
    KS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER REPORTED VIA PHONE CALL OF CUSTOMER'S HIGH BLOOD GLUCOSE LEVELS AND NO DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 400MG/DL. THE CUSTOMER'S MOST CURRENT LEVEL WAS 363MG/DL. THE CUSTOMER STATES THEY TREATED WITH MANUAL INJECTIONS. TROUBLESHOOT WAS UNABLE TO BE COMPLETED. THE FATHER STATES THEY WOULD CALL BACK AT A LATER TIME WHEN WIFE WAS PRESENT, IN ORDER TO COMPLETE TROUBLESHOOT. THE CUSTOMER IS BEING SENT SAMPLE SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614513 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other