BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3812689 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-84657
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    February 15, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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 BEING HOSPITALIZED WITH LOW BLOOD GLUCOSE OF 19MG/DL IN (B)(6) 2013. THE CUSTOMER WAS UNCONSCIOUS AND THE DAUGHTER COULD NOT GET HER TO RESPOND, THEN THE PARAMEDICS WERE CALLED. THE CUSTOMER STATED THAT SHE HAD LOST 100 POUNDS. THE CUSTOMER HAD THE HYPOGLYCEMIA EPISODE WHILE SLEEPING. THE CALLER STATED THAT THE CAUSE OF HER LOW GLUCOSE WAS FEELING SICK AND TOO MUCH INSULIN. THE CUSTOMER ALSO REPORTED BEING IN THE EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE OVER 500MG/DL, AND SHE WAS TREATED WITH AN INSULIN DRIP. IT WAS STATED THAT THE CAUSE OF THE EMERGENCY ROOM VISIT WAS DRINKING AND SUICIDAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290615 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization