BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3830668 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84930
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    December 18, 2013
    Report Date
    May 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 WAS HOSPITALIZED DUE TO A DIABETIC SEIZURE AND LOW BLOOD GLUCOSE. THE CUSTOMER HAD TO HAVE SURGERY AS A RESULT OF THIS DIABETIC SEIZURE. THE BLOOD GLUCOSE READING WAS 28 MG/DL AT THE TIME OF THE SEIZURE. ALSO, ON 05/04/2014, THE CUSTOMER STATED THAT THERE WAS NO INSULIN SHOWING IN THE RESERVOIR ICON. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308300 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization