BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3831237 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84999
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CALLED TO REPORT HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE AND FRACTURED FIBULA. CUSTOMER STATED HE BROKE HIS ANKLE FROM PASSING OUT DUE TO LOW BLOOD GLUCOSE. BLOOD GLUCOSE WAS 12 MG/DL. CUSTOMER WAS GIVEN INTRAVENOUS DRIP TREATMENT AT THE HOSPITAL FOR LOW BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308268 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization