BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4860592 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67670
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    May 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 VIA PHONE CALL THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 35 MG/DL. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL. CUSTOMER WAS IN THE EMERGENCY ROOM FOR 5 HOURS AND WENT TO DOCTORS, GOT 2 GLYCOGEN SHOTS AS BACKUP PLAN. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP AND CALL BACK IF ISSUES PERSIST. THE CUSTOMER ALSO REPORTED VIA PHONE CALL THAT SHE HAD A HIGH BLOOD GLUCOSE BUT NOT HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN MG/DL. THE CUSTOMER STATED, THEY DON HAVE A BACKUP PLAN AVAILABLE. THE CUSTOMER WAS ADVISED TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT. CUSTOMER WAS ADVISED TO CALL WHEN TUBING CLAMP RECEIVED TO PERFORM HIGH PRESSURE TEST. THE CUSTOMER WAS ASSISTED WITH PROGRAMMING BASAL RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402767 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization