BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3954149 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-88107
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 946 MG/DL AND KETONES. THE CUSTOMER HAD SHORTNESS OF BREATH AND DRY MOUTH. THE CALLER STATED THAT THEY FELT THE INSULIN PUMP AND THE SENSOR WERE NOT WORKING CORRECTLY. THE CUSTOMER WAS TREATED WITH IV DRIP. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION BUT THE CUSTOMER STATED THAT THEY WERE DISCONNECTED FROM THE DEVICE FOR ONE DAY PRIOR TO THE HOSPITALIZATION. AT THE TIME OF THE CALL TROUBLESHOOTING WAS NOT PERFORMED BECAUSE THE NURSE HAD THE DEVICE AND THE CUSTOMER WAS NOT FEELING WELL. THE CALLER WAS ADVISED THAT TROUBLESHOOTING IS DONE OVER THE PHONE. THE CALLER STATED THAT THEY WILL INFORM THE CUSTOMER AND WILL HAVE THE CUSTOMER CALL BACK FOR TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430612 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization