BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4243673 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50317
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS HOSPITALIZED. THE CUSTOMER BELIEVED THEY HAD PUT ON THEIR INSULIN PUMP INCORRECTLY. IT WAS ALSO FOUND THE CUSTOMER DID NOT HAVE DIABETES KETOACIDOSIS. THE CUSTOMER WAS NOT WELL TO PROVIDE FURTHER INFORMATION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727538 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization