BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5127904 · Received October 5, 2015

    Report

    Report Number
    2032227-2015-53105
    Event Type
    Injury
    Date Received
    October 5, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 HAD HIGH BLOOD GLUCOSE BUT NOT HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE WAS 526 MG/DL. THE CUSTOMER REPORTS THEY HAVE A BACKUP PLAN AVAILABLE. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. AFTER THE TROUBLESHOOTING WAS DONE, CUSTOMER WAS ADVISED TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT. CUSTOMER WAS ADVISED THAT THE DEVICE IS WORKING AS IT SHOULD ACCORDING TO THE TROUBLESHOOTING AND MONITOR AND CALL BACK KIF ANY ISSUES CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657558 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other