BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4780682 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57370
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 22, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED HE WAS TREATED BY PARAMEDICS FOR LOW BLOOD GLUCOSE OF 48 MG/DL. LEADING UP TO THE PARAMEDICS TREATING THE CUSTOMER, HIS SENSOR GAVE A READING OF OVER 400 MG/DL AND THE CUSTOMER TREATED OFF OF THIS READING WITHOUT CONFIRMING BLOOD GLUCOSE VALUE FIRST. AS A RESULT, THE CUSTOMER DELIVERED TOO MUCH INSULIN IN A BOLUS. THE CUSTOMER DECLINED TO TROUBLESHOOT THE INSULIN PUMP. HE WAS ADVISED TO TURN THE SENSOR OFF, WAIT FOR BLOOD GLUCOSE TO STABILIZE, AND TO TURN THE SENSOR BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325731 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention