BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3223144 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-95615
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 800MG/DL. THE CALLER STATED THAT HE WAS VERY SICK AND VOMITING. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS HIGH AND BOLUSED, BUT IT KEPT GOING HIGHER; THEN HE KEPT THROWING UP EVEN BLOOD AND ENDED IN THE HOSPITAL. THE CALLER STATED THAT THE TIME AND DATE WERE NOT SETTING PROPERLY. THE CUSTOMER STATED THAT HE GOT A NO DELIVERY ALARM, AND HE CHANGED THE INFUSION SET. HOWEVER, TWO DAYS LATER HE GOT SICK AGAIN. TROUBLESHOOTING COULD NOT BE PERFORMED AS CUSTOMER STATED THAT THEY REMOVED THE BATTERY AFTER HE WAS ADMITTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323087 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization