BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4781606 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57663
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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 REPORTED VIA PHONE CALL THAT THEY HAD AN UNEXPECTED RESTART ALARM ON THE INSULIN PUMP. CUSTOMER ALSO REPORTED A HIGH PITCH NOISE EMITTING FROM THE INSULIN PUMP. CUSTOMER WAS ABLE TO RESOLVE THE NOISE BY REPLACING THE BATTERY. IT WAS ALSO FOUND THERE WAS A SOLID CIRCLE ON THE INSULIN PUMP'S DISPLAY. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. IT WAS REPORTED THE UNEXPECTED RESTART ALARM WAS RECURRING DURING NORMAL USE. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325187 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR