BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090109 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81346
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    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 HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 33MG/DL. THE CUSTOMER DRANK ORANGE JUICE AND HER GLUCOSE WENT UP TO 49MG/DL. IT WAS REPORTED THAT THE CUSTOMER HAS SYMPTOMS OF BEING INCOHERENT, CONFUSION, VOMITING, AND SHAKING. IT WAS STATED THAT THE CUSTOMER IS ON A MEDICATION FOR SEIZURES. IT WAS STATED THAT THE CUSTOMER SAW HER ENDOCRINOLOGIST DOCTOR AND THE PROGRAM IN THE INSULIN PUMP WAS CHANGED. ADVISED THE CUSTOMER TO TAKE ANOTHER READING AND HER BLOOD GLUCOSE WAS 69MG/DL. OFFERED TO CALL PARAMEDICS AND CUSTOMER STATED THAT SHE IS GOING TO THE HOSPITAL IN AN AMBULANCE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization