BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3942988 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87637
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 CUSTOMER STATED THAT THE INSULIN PUMP ALARMED LOST SENSOR. THEY STATED THAT THE SENSORS WERE NOT LASTING SEVEN DAYS. THE TRANSMITTER DOES NOT HOLD CHARGE. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN SINCE THE REPORTED ISSUE WAS A PAST EVENT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WAS NOT LONGER RECEIVING DATA FROM THE TRANSMITTER. THE CUSTOMER STATED THAT COMMUNICATION WAS NOT ESTABLISHED BETWEEN THE INSULIN PUMP AND THE SENSOR. ALL OF THE SETTINGS WERE CORRECT. THE CUSTOMER STATED THAT THEY DID NOT SEE A BENT CANNULA WHEN THE SENSOR WAS REMOVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419117 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR