BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3850009 · Received June 4, 2014

    Report

    Report Number
    3004209178-2014-85430
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 29, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS FOUND UNCONSCIOUS AND CURRENTLY IS HOSPITALIZED. THE CUSTOMER WAS IN A COMA AND HAS SUFFERED BRAIN DAMAGE. THE CUSTOMER HAD BEEN UNCONSCIOUS FOR OVER 24 HOURS WHEN FOUND. HE WAS ADMITTED WITH BLOOD GLUCOSE OF 1MMOL/L. THE CARELINK REPORT WAS DOWNLOADED AND WAS SHOWING THE DAILY TOTAL OF 50.4 UNITS OF INSULIN APART FROM (B)(6) WHERE IT HAS BEEN STOPPED ON 30.4 UNITS. IT WAS BELIEVED THIS IS WHEN THE CUSTOMER WAS ADMITTED TO THE HOSPITAL. HE HAS NOT GIVEN ANY BOLUS THROUGH THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325895 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization