BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3895484 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-86135
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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

    CUSTOMER REPORTED HOSPITALIZATION DUE TO DIABETES KETOACIDOSIS. CUSTOMER STATED THAT HE HAS NEVER FELT SO BAD IN HIS LIFE. CUSTOMER WAS VOMITING EVERY 15 MINUTES. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 370 MG/DL. CUSTOMER WAS HOSPITALIZED FOR THREE DAYS. THE CURRENT BLOOD GLUCOSE READING IS 193 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370209 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization