BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920869 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86532
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 AN EMERGENCY ROOM VISIT DUE TO LOW BLOOD GLUCOSE. HE STATED THAT IT WAS COMPLETELY HIS FAULT, HE SHOULD HAVE TAKEN THE INSULIN PUMP OFF BECAUSE HE HAD A VERY ACTIVE AND STRENUOUS DAY; HE WAS CUTTING TREES AND WAS SWEATING A LOT. HE WOKE UP IN THE MIDDLE OF THE NIGHT AND HIS VISION WAS BLURRED. HE TRIED TREATING THE LOW BLOOD GLUCOSE BUT IT DID NOT WORK, SO HE WENT TO THE EMERGENCY ROOM. THE BLOOD GLUCOSE AT THE TIME OF THE ADMITTANCE WAS 21 MG/DL. THE CUSTOMER WAS TREATED WITH IV FOR AN HOUR AND A HALF AND THEN WAS RELEASED. AT THE TIME OF THE PHONE CALL THE CUSTOMER WAS ALSO REPORTING AN ALARM THAT HE RECEIVED ON THE INSULIN PUMP THREE TO FOUR WEEKS PRIOR TO THE CALL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398453 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization