BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3854816 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85478
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    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

    THE CUSTOMER REPORTED ENDING IN THE HOSPITAL A MONTH AGO WITH HIGH BLOOD GLUCOSE OF 400MG/DL AND WAS WITHOUT EATING OR DRINKING. THE CALLER STATED THAT THE CANNULA WAS REALLY BENT. THE CUSTOMER IS COMFORTABLE WITH THE INSERTION AND NO ISSUE SINCE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332947 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization