BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3831163 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84960
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. CUSTOMER STATES SHE HAD A CLOGGED INFUSION SET, AND HAD TO CHANGE THE SET FOUR TIMES. THE CUSTOMER ALSO STATED THAT SHE KEPT GETTING NO DELIVERY ALARMS. CUSTOMER HAD BLOOD GLUCOSE READING OF 517 MG/DL BEFORE HOSPITALIZATION. OFFERED TO TROUBLESHOOT THE PUMP BUT CUSTOMER DECLINED. CUSTOMER SPENT THE NIGHT AND RELEASED THE FOLLOWING EVENING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308362 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization