BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3885184 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-86060
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN EMERGENCY ROOM VISIT DUE TO HIGH BLOOD GLUCOSE READINGS OF OVER 400 MG/DL. THE CUSTOMER REPORTED DISSATISFACTION WITH THE INSULIN PUMP AND STATED THAT THE MIO INFUSION SET IS KINKED. THE CUSTOMER DECLINED TO SPEAK WITH HELP LINE FOR ASSISTANCE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361459 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization