BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3885194 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-86063
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    CUSTOMER REPORTED HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CUSTOMER STATED THAT SHE WOKE UP IN THE MIDDLE OF THE NIGHT WITH BLOOD GLUCOSE LEVEL OF 40 MG/DL. CUSTOMER TREATED WITH JUICE AND THE BLOOD GLUCOSE HAD GONE UP TO 80 MG/DL 15 MINUTES LATER. CUSTOMER STATED THAT HER BODY WAS THROBBING, HEART WAS RACING AND THE AMBULANCE WAS CALLED. CUSTOMER STATED THAT SHE WAS TREATED FOR HIGH BLOOD PRESSURE AT THE HOSPITAL. CUSTOMER WAS NOT TREATED FOR THE BLOOD GLUCOSE LEVELS. CUSTOMER ALSO STATED THAT THE DOCTOR WROTE HEART PALPATIONS DUE TO LOW BLOOD GLUCOSE IN HIS NOTES. CUSTOMER STATED THAT SHE BELIEVES THE REASON FOR HER LOWS MAY HAVE BEEN EXERCISE THROUGHOUT THE DAY, NOT EATING ON TIME AND THE LITTLE SNACK BEFORE BED. CUSTOMER ALSO FELT THAT THE BOLUS WIZARD RECOMMENDED MORE INSULIN THAN SHE FELT WAS NEEDED. THROUGH TROUBLESHOOTING, AIR BUBBLES WERE NOTED IN THE RESERVOIR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361480 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization