BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3791280 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84297
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 KETONES AND HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CUSTOMER WAS THROWING UP AT THE TIME THE PARAMEDICS WERE CALLED. THE CUSTOMER WAS TREATED WITH AN INSULIN DRIP AND HAS NOT BEEN ON THE DEVICE FOR TWO DAYS. THE CALLER MENTIONED THAT THE CANNULA WAS BENT. TROUBLESHOOTING WAS DECLINED AS CUSTOMER HAD VISITED HER DOCTOR THE DAY OF CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268394 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization