BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4920224 · Received July 16, 2015

    Report

    Report Number
    3004209178-2015-74896
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 NURSE REPORTED VIA PHONE CALL BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE WAS 912 MG/DL. THE CALLER STATED THAT THE CUSTOMER HAD BEEN AT A CASINO, WAS NOT FEELING WELL, AND LEFT TO BE ADMITTED INTO THE HOSPITAL. THE CUSTOMER WAS STILL IN THE HOSPITAL AT THE TIME OF THE CALL AND WAS TREATED WITH INTRAVENOUS INSULIN. SHE HAD HER HEART MONITORED AS WELL. THE CALLER STATED THAT THE CUSTOMER HAD BEEN WEARING THE INSULIN PUMP AT THE TIME OF THE EVENT. NO PHYSICAL DAMAGE TO THE INSULIN PUMP WAS NOTED. THE CALLER WAS ADVISED TO CALL THE DIABETES CLINICAL MANAGER TO ADDRESS A POSSIBLE ISSUE AND TO TEST THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462564 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization