BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2944770 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-90819
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 23, 2013
    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 DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 350MG/DL BY THE TIME THE PARAMEDICS WERE CALLED. THE CUSTOMER FELT VERY ILL, VOMITING, EXTREMELY WEAK, AND HAD SEVERE DEHYDRATION. IT WAS STATED THAT THE CUSTOMER HAS BEEN USING THE INSULIN PUMP FOR FIVE DAYS AND THE DOCTOR AT THE HOSPITAL TOOK OFF THE DEVICE, AND THEN SHE WENT TO HER ENDOCRINOLOGIST, WHO RECOMMENDED STAYING OFF THE INSULIN PUMP FOR A WHILE. THE CUSTOMER STATED THAT SHE MAYBE NEEDED MORE INSULIN AND A HIGH DOSE OF BASAL AS THEY PUT HER ON A VERY LOW DOSE OF INSULIN TO KEEP HER FROM AVOIDING LOWS. THE CUSTOMER STATED THAT HER DOCTOR INCREASED THE BASAL TWO TIMES AND HER BLOOD GLUCOSE WAS STILL HIGH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48805 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization