BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4823078 · Received June 6, 2015

    Report

    Report Number
    3004209178-2015-63340
    Event Type
    Injury
    Date Received
    June 6, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S FATHER REPORTED VIA PHONE CALL THAT CUSTOMER RECEIVED A SPANISH SOFTWARE ANOMALY. CALLER WAS ADVISED TO MONITOR INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 50 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366812 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR