BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3903536 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86400
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 THAT SHE HAD PROBLEM WITH HER ORIGINAL INSULIN PUMP AND ENDED IN THE HOSPITAL. THE CUSTOMER SENT IT BACK THE OTHER INSULIN PUMP AND WANTED TO KNOW IF SHE NEEDS TO BE CALLED FOR TRAINING. ASSISTED THE CUSTOMER TO E-MAILED TWO DIFFERENT DIABETES EDUCATORS TO SEE WHO IS GOING TO HANDLE THE TRAINING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379453 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization