BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4003650 · Received August 12, 2014

    Report

    Report Number
    3004209178-2014-92596
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 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

    CUSTOMER COMPLAINED ABOUT RECEIVING SENSOR ALERTS WHEN SHE IS SLEEPING AT NIGHT. CUSTOMER STATED THAT THE SENSOR GLUCOSE READINGS SAY THAT SHE IS RISING UPON WAKING. CUSTOMER STATED THAT SHE HAS A SENSOR THAT STOPPED WORKING AFTER THREE DAYS OF INSERTION. CUSTOMER STATED THAT A SMALL AMOUNT OF ACTIVITY SEEMS TO YIELD MOST OF THE SENSOR ACTIVITY. CUSTOMER DECLINED ON BEING ASSISTED OR TROUBLESHOOTING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478679 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR