BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3183265 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-94914
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 HAVING LOW BLOOD GLUCOSE WHILE BEING AT THE HOSPITAL FOR KNEE SURGERY. AT THE TIME THEY HAD THE CUSTOMER AT 50% OF INSULIN INTAKE. THE CUSTOMER STATED THAT HE WENT TO ENDOCRINOLOGIST THE DAY BEFORE AND THEY RAISED THE CARBOHYDRATES FROM 3:1 TO 5:1, BUT HE WENT INTO A HYPOGLYCEMIC EPISODE AGAIN. TROUBLESHOOTING WAS DECLINED AS CUSTOMER REQUESTED ASSISTANCE TO LOWER HIS BASAL RATE OVERNIGHT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282746 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 79 YR Hospitalization