BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945567 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87851
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    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

    DURING A FOLLOW UP CALL THE CALLER STATED THAT THE CUSTOMER'S INSULIN PUMP WAS ALARMING WEAK SIGNAL AND LOST SENSOR WHILE THE CUSTOMER WAS SLEEPING. BUT, WHEN THE LOST SENSOR ALERT OCCURS THE CUSTOMER IS ABLE TO FIND SENSOR. THE CALLER STATED THAT THE CUSTOMER SLEEPS ON THE PUMP. THE CALLER STATED THAT THEY CANNOT RECALL WHEN THE ISSUE LAST OCCURRED. SINCE THE REPORTED ISSUE WAS A PAST EVENT THE CUSTOMER'S BLOOD GLUCOSE WAS NOT REPORTED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424390 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR