BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4811069 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61389
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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

    THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE PATIENT WAS NOT FEELING WELL AND VOMITING, AND HIS BLOOD GLUCOSE WAS 444 MG/DL. THEY CHANGED OUT THE SET, BUT HIS BLOOD GLUCOSE WOULD NOT COME DOWN. THE CUSTOMER'S PARENT DECLINED TO BE TRANSFERRED FOR FURTHER ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356435 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR